Senior Manager, Data Integrity & Governance

Job Description Job Description Position Summary The Senior Manager, Data Integrity & Governance is responsible for leading and managing the Sharp Sterile Manufacturing site data integrity initiatives, with a focus on ensuring the accuracy, completeness, consistency, and reliability of GXP data across computerized and paper-based systems. The role will oversee the site’s development, implementation, and monitoring of data integrity processes, policies, and tools that align with regulatory requirements, and enable adherence to ALCOA principles. The site Data Integrity Lead will work closely with the site functions including; IT, Manufacturing, Quality and Engineering to enable Data Integrity compliance using a Quality risk management approach. The site Data Integrity Lead will collaborate with the Director, Data Integrity at the Allentown site to ensure alignment with corporate initiatives and the consistent implementation of Data Integrity standards, governance practices, risk assessment methodologies, training programs, and continuous improvement activities across the organization. The primary responsibilities of this role include site training on the requirements of ALCOA, ensuring processes and procedures are in place to implement ALCOA principles in paper and computerized systems, ensuring that computerized system access controls, audit trail reviews and back-up and restore functions are appropriately implemented and meet cGMP requirements. The site Data Integrity Lead will also have responsibility for implementing and maintaining risk-based methodologies for the assessment and management of data integrity risks. The site Data Integrity Lead will drive a Data Integrity Management program across the Lee, MA manufacturing facility. This site-based role requires a strong leader with excellent communication skills and who is capable of prioritizing and managing multiple projects effectively. The successful candidate will be responsible for ensuring cGMP compliance as it pertains to Data Integrity Management across site operations and for implementing applicable corporate standards locally. Duties and Responsibilities Lead and maintain the site Data Integrity Management Program, including defining site objectives and scope, implementing corporate data integrity requirements, development and refinement of site procedures, implementing processes and metrics to monitor the effectiveness of the site Data Integrity program. Serve as the site Data Integrity subject matter expert (SME) during regulatory inspections and client audits, train/coach personnel on ALCOA principles and associated regulations and guidance documents. (e.g. GAMP5, PIC/S, 21 CFR Part 11, EudraLex Annex 11, FDA’s Guidance for Industry, “Data Integrity and Compliance with Drug CGMP: Questions and Answers” (Final, 2018)). Report to the Site Quality Head and serve on the site Quality Leadership team and governance forums. Provide leadership and guidance to site functional representatives and system or process owners supporting Data Integrity objectives. Ensure site personnel understand and implement risk-based methodologies are understood and implemented as they pertain to data integrity management, especially when assessing legacy computerized systems, when validating new computerized systems and when evaluating proposed changes to existing computerized systems. Collaborate with the applicable corporate and site Data Governance, Quality, and Information Technology functions to integrate data integrity into the overall data governance framework, with particular emphasis on computerized systems and adherence to ALCOA principles. Collaborate cross-site to ensure that roles and responsibilities are clear regarding data management and stewardship of data integrity management. Provide guidance on the process to evaluate data integrity compliance through audits of Sharp and its suppliers. Lead or support site Data Integrity risk assessments, investigations, root cause analyses, corrective and preventive actions, and remediation plans. Ensure Data Integrity considerations are incorporated into computerized system validation, change control, incident management, periodic review, and system retirement activities. Review and trend site Data Integrity metrics, communicate program status and risks to site leadership, and drive continuous improvement and inspection readiness. Monitor relevant regulatory and industry expectations, assess site impact, and coordinate implementation of required site actions. Regulatory Responsibilities Conduct business in a responsible manner that complies with all state, OSHA, and HIPAA regulations Maintain a detailed and comprehensive understanding of FDA, EU, and other regulatory agency requirements as it pertains to data integrity. Supervisory Responsibilities This position has no direct reporting line responsibility; however, it will provide functional leadership and oversight to Data Integrity representatives and subject matter experts embedded within site operational units to support the execution of the Data Integrity Program. Experience Prefer a minimum of 5 years of experience in data management, data governance frameworks, and data quality tools, with a focus on computerized systems and adherence to ALCOA principles. Also prefer a minimum of at least 1.5 years in a leadership role within a pharmaceutical operation. Expertise in the application of 21 CFR Part 11, EudraLex Annex 11 and GAMP standards for data integrity and validation of automated systems is required. Proven experience of managing data integrity initiatives, particularly in relation to computerized systems, within a pharmaceutical organization. Experience collaborating cross functionally on investigations, CAPAs, risk assessments, and remediation programs associated with Data Integrity events or observations. Demonstrated history of influencing, motivating and effecting change with cross‐functional teams. Ability to independently determine and develop approaches to address simple to complex issues. Knowledge of and skill in using computer software and hardware applications. Excellent verbal and written communication/documentation skills with a demonstrated ability to clearly present technical topics to a non‐technical audience. Ability to influence and engage stakeholders at all levels. Excellent project management skills with the ability to manage multiple initiatives simultaneously. Strong analytical skills with the ability to interpret complex data sets from computerized systems and provide actionable insights. Experience of working in a sterile pharmaceutical manufacturing environment preferred. Education BS or higher degree in an IT, engineering, scientific discipline or other related field. A master’s degree is a plus. Knowledge, Skills & Abilities Skilled in the use of Microsoft office applications (Word, Excel, PowerPoint) and Adobe Acrobat High attention to detail Good writing, public speaking and presentation skills Must be able to travel approximately 10% of the time Physical Requirements Ability to sit for prolonged periods of time Ability to stand for prolong periods of time as required Able to lift up to 10lbs

Mechanical Gage Calibration & Repair Technician

Job Description Job Description Job Description: Performs calibration and repairs on mechanical hand tool gages such as calipers, micrometers, indicators, torque tools, pressure gages, height gages, Force gages, pressure gages etc. Ideal candidate should have experience using and repairing most types of inspection gaging. Calibration is performed to applicable standards and procedures. Gages that require repair will have worn and broken parts replaced as required in order to return gages back to proper functionality and compliance to the required specified tolerances and standards. Will train qualified candidates. Job Duties (include but not limited to): All work is performed in accordance to specific procedures that comply with various standards and specifications. Calibration data is collected by taking measurements and recording the readings in QCS custom developed applications for generation of Long Form Certificate of Calibration. Where applicable, adjustments, and repairs are made to bring the gages/ instruments into tolerance. Requires knowledge of gage application and functionality and be able to determine if a gage is in or out of tolerance by performing basic math. Must be able to follow and understand the calibration and repair procedures & techniques while possessing the appropriate analytical abilities. Qualifications · Must be capable of working effectively individually or in a team environment. · 2 year technical school degree or equivalent level of education and/or work experience in a Quality or manufacturing discipline where gages were used, or Military (PMEL) training /experience. · Must be able to follow verbal and written instruction. · Good Math Skills · Must possess initiative and self motivation. · Ability to obtain and maintain accurate records & certifications. · Strong computer skills · Ability to work with data bases and know how to properly store and retrieve data · Good Mechanical Aptitude · Good Troubleshooting skills · Must have good communication skills and a professional appearance due to interface with customers. Benefits · Health Insurance · Dental Insurance · 401K Plan · Paid Vacation · Vision Insurance · Paid Holidays \nCompany Description QCS is an ISO/IEC 17025 Accredited full service metrology lab established in 1984 that provides calibration services to the Aerospace, Automotive, Defense, Medical, Nuclear, and all other General, Manufacturing sectors. QCS calibrates Hard Gages (i.e. Gage Blocks, Cylindrical and Threaded - Plugs, Rings, & Pins, etc.), QCS also performs calibration and repair of Electro-Mechanical Gage Hand Tools (i.e. Micrometers, Calipers, Indicators, Torque, Force, Pressure, Height Gages, Mass, etc.), Electronic Test & Measurement Equipment (Oscilloscopes, Multi-meters, Frequency Counters, Signal Generators, Hypots,etc.).OCS offers on-site services for the calibration of CMM’s, Hand Tools, Surface Plates, Optical Comparators, Hardness Testers, Electronic Instrumentation, and more. In addition QCS provides 1st Article Dimensional Inspection Services utilizing our touch probe and Video CMM’s) QCS has one of the broadest scopes of Accreditation of any lab in the country while maintaining one of the finest reputations in the industry for nearly 40 years. QCS has one of the finest Metrology facilities in the country containing 6 state of the art climate & environmentally controlled laboratories situated within our 20K sq. ft building providing an extremely pleasurable working environment. Company Description QCS is an ISO/IEC 17025 Accredited full service metrology lab established in 1984 that provides calibration services to the Aerospace, Automotive, Defense, Medical, Nuclear, and all other General, Manufacturing sectors. QCS calibrates Hard Gages (i.e. Gage Blocks, Cylindrical and Threaded - Plugs, Rings, & Pins, etc.), QCS also performs calibration and repair of Electro-Mechanical Gage Hand Tools (i.e. Micrometers, Calipers, Indicators, Torque, Force, Pressure, Height Gages, Mass, etc.), Electronic Test & Measurement Equipment (Oscilloscopes, Multi-meters, Frequency Counters, Signal Generators, Hypots,etc.).OCS offers on-site services for the calibration of CMM’s, Hand Tools, Surface Plates, Optical Comparators, Hardness Testers, Electronic Instrumentation, and more. In addition QCS provides 1st Article Dimensional Inspection Services utilizing our touch probe and Video CMM’s)\r\n\r\n\r\n\r\nQCS has one of the broadest scopes of Accreditation of any lab in the country while maintaining one of the finest reputations in the industry for nearly 40 years. QCS has one of the finest Metrology facilities in the country containing 6 state of the art climate & environmentally controlled laboratories situated within our 20K sq. ft building providing an extremely pleasurable working environment.

HVAC Installer

Job Description Job Description About the Role: 3-5 years experience needed in the field as an installer is preferred. New construction installation of HVAC systems inside of residential homes and commercial buildings. Ductwork, furnaces, ac lines and venting. This will happen year round in all weather conditions. At times required to wear all proper PPE and hi-vis clothing. During the installs the pay will be an hourly rate for the first 90 days while being evaluated, then will go to piece rate. *Very good quality installers with good speed and accuracy can make 75k - 100k per year! Responsibilities: Install, heating and air conditioning systems in residential and commercial properties. Diagnose and troubleshoot HVAC issues, providing effective solutions in a timely manner. Communicate with job site superintendents about plans. Maintain accurate records of installations to be given to the office staff. Adhere to safety protocols and regulations while working on HVAC systems. Collaborate with team members to improve efficiency and customer satisfaction. Stay updated on industry trends and advancements in HVAC technology. Requirements: High school diploma or equivalent. Minimum of 3 years of experience in HVAC installation. Valid driver's license and clean driving record. Strong installation skills and attention to detail. Excellent communication skills. Ability to work independently and as part of a team. Knowledge of local HVAC codes and regulations. Willingness to work flexible hours, including evenings and weekends. About Us: Brozwood has been serving in the HVAC community for almost a decade, providing reliable and high-quality HVAC services. Our customers love us for our commitment to excellence and our friendly, knowledgeable staff. Employees enjoy a supportive work environment that fosters growth and teamwork, making Brozwood a great place to build a career.

HVAC Helper - New Construction & Apartment Remodels

Job Description Job Description Omega General & Electrical Contractors LLC is seeking a self-motivated HVAC Helper to join our growing team. We specialize in new construction and apartment renovation projects and are looking for someone who is dependable, hardworking, and eager to build a long-term career in the HVAC trade. Responsibilities Assist HVAC mechanics with installing ductwork, equipment, refrigerant piping, grilles, registers, and ventilation systems. Help with apartment HVAC remodels, equipment replacements, and new construction installations. Load, unload, and organize tools, materials, and equipment. Maintain a clean, organized, and safe job site. Follow all company safety policies and procedures. Perform general labor and assist with daily project tasks. Travel to job sites throughout the El Paso area and surrounding locations as needed. Qualifications Self-motivated with a strong work ethic and positive attitude. Reliable, punctual, and dependable. Willingness to learn and grow in the HVAC industry. Ability to lift up to 75 pounds and work in various weather conditions. Comfortable using hand and power tools. Valid driver’s license and reliable transportation preferred. Previous construction or HVAC experience is a plus, but not required. We are willing to train the right candidate. What We Offer Full-time, year-round employment. Competitive pay based on experience. Opportunities for advancement into HVAC Installer and HVAC Mechanic positions. Hands-on training with experienced professionals. A team-oriented work environment focused on safety, quality, and career growth. If you’re dependable, enjoy working with your hands, and want to build a career in commercial HVAC construction, we’d love to hear from you. Apply today and grow with Omega General & Electrical Contractors LLC! \nCompany Description Omega General & Electrical Contractors LLC is a growing construction company specializing in electrical, HVAC, commercial construction, government contracts, and real estate development. We are looking for a highly organized, professional, and energetic individual to become the face of our company. Company Description Omega General & Electrical Contractors LLC is a growing construction company specializing in electrical, HVAC, commercial construction, government contracts, and real estate development. We are looking for a highly organized, professional, and energetic individual to become the face of our company.

Commercial Hvac Service Technician

Job Description Job Description We are looking for experienced commercial HVAC Service Technicians to join our team! You will install, service, and repair heating and air conditioning systems. Responsibilities: Install new heating, ventilation, and air conditioning systems Inspect and perform equipment repairs and replacements Perform routine preventative maintenance Respond to emergency maintenance requests Adhere to all safety policies and procedures Qualifications: Previous experience in commercial HVAC Familiarity with HVAC wiring diagrams Ability to handle physical workload Strong problem solving and critical thinking skills \nCompany Description Cayce Company opened its doors in 1956 and has actively participated in the welcomed expansion of institutional, commercial, and industrial construction in the Southeast ever since. Today, Cayce Company is leading the way in mechanical contracting and operates from the mountains to the seashore—designing, installing, and servicing systems ranging from plumbing to electrical to mechanical and much more. With unlimited licensing and bonding across the Southeast—in North Carolina, South Carolina, Florida, Virginia, Georgia, Alabama, Tennessee, and Maryland—Cayce continues to build the future for clients of all sizes. Company Description Cayce Company opened its doors in 1956 and has actively participated in the welcomed expansion of institutional, commercial, and industrial construction in the Southeast ever since. Today, Cayce Company is leading the way in mechanical contracting and operates from the mountains to the seashore—designing, installing, and servicing systems ranging from plumbing to electrical to mechanical and much more. With unlimited licensing and bonding across the Southeast—in North Carolina, South Carolina, Florida, Virginia, Georgia, Alabama, Tennessee, and Maryland—Cayce continues to build the future for clients of all sizes.

Traveling Data Center Technician

Job Description Job Description Job description Must be comfortable with a lot of travel. Candidates will need to be working out of different locations within a 72 hour notice. Client will provide all travel arrangements. Position summary The Traveling Data Center Installation Technician travels to customer sites to support new data center launches, expansions, and equipment deployments. The technician receives, moves, assembles, positions, and equips server racks and cabinets, also referred to as data towers, according to approved layouts and instructions. The position supports safe, accurate project completion through component installation, cable routing, inventory control, quality checks, and installation records. Essential duties and responsibilities · Receive, unpack, inspect, and stage racks, servers, network equipment, cables, and installation materials. Report shortages, damage, and discrepancies. · Move and position racks and cabinets using approved rack movers, pallet jacks, lifting devices, and team handling methods. Verify placement against floor plans and measurements. · Assemble racks and install rails, brackets, shelves, panels, and cable management hardware using appropriate tools and specified torque requirements. · Mount servers and authorized components in designated rack positions following installation drawings, manufacturer instructions, and customer standards. · Route, secure, dress, and label copper and fiber cables; make approved connections while protecting cable bend radius, connectors, airflow, and service access. · Perform assigned visual inspections and basic installation or connectivity checks within the technician’s training and authorization. Escalate defects and technical issues to qualified personnel. · Record asset identifiers, serial numbers, rack locations, completed tasks, and discrepancies in inventory systems, work orders, and installation checklists. · Coordinate with deployment leads, customer representatives, warehouse teams, and technical staff to sequence work and meet project milestones. · Follow site access, confidentiality, asset protection, and data security requirements. · Use required personal protective equipment and electrostatic discharge controls. Follow applicable equipment handling, electrical safety, and energy isolation procedures. Stop and report unsafe work. · Operate powered material handling equipment only after required training and site authorization. Use mechanical assistance and team handling for heavy or awkward equipment. · Maintain clean, organized work areas, remove packaging, and segregate waste under site procedures. Complete handoff records and support resolution of installation punch list items. · Perform related deployment or assigned home site duties consistent with training and business needs. Scope of authorized work Electrical circuit installation energized electrical work, equipment energization, and advanced server or network configuration require separately qualified and authorized personnel. This role performs only tasks within the approved project scope and the employee’s training. Required qualifications · High school diploma or equivalent, or equivalent relevant training and experience. · At least one year of related experience in data center deployment, server rack assembly, hardware installation, electronics assembly, structured cabling, or comparable equipment installation. · Ability to read work instructions, rack elevations, floor plans, diagrams, part numbers, and installation checklists. · Ability to use hand tools, approved power tools, and measuring devices safely and accurately. · Basic computer skills for inventory transactions, work orders, email, and project documentation. · Ability to travel for extended assignments and work assigned schedules, including nights, weekends, and overtime when required. · Strong attention to detail, dependable attendance, clear communication, and ability to collaborate with different site teams. Preferred qualifications · Experience in customer data centers or large-scale technology deployment environments. · Familiarity with server components, rack hardware, copper and fiber cabling, asset tracking, and electrostatic discharge precautions. · Relevant technical training or certifications such as CompTIA A, structured cabling training, or material handling equipment training. Travel and scheduling expectations This traveling field position requires frequent overnight travel and temporary assignments away from the employee’s home location. Travel percentage, assignment duration, reporting location, and work schedules will be communicated before deployment and may change with customer project needs. Between deployments, employees may support an approved local site in related operational duties. Travel arrangements, lodging, eligible expenses, and applicable allowances follow the approved company travel policy. Employees must accurately record all work and travel time as instructed. Travel time and overtime will be paid as required by applicable law and company policy. Physical demands and work environment Essential functions involve prolonged standing and walking, bending, kneeling, reaching, handling tools and small components, and pushing or pulling equipment with approved aids. Work may include lifting and carrying components up to 50 pounds, and accessing racks from approved platforms or ladders. Heavy or awkward items require mechanical assistance or team handling. Specific lifting limits and task frequencies must be confirmed through the site job assessment. Work occurs in data centers, staging areas, and warehouse or active deployment environments with equipment noise, temperature variation, restricted access, and nearby material handling activity. Employees must follow applicable site safety rules. Essential functions may be performed with or without reasonable accommodation. Performance expectations · Complete installations accurately and within agreed project milestones. · Maintain reliable asset and task records, promptly report discrepancies, and minimize avoidable damage and rework. · Demonstrate safe work practices, protect customer assets and information, and communicate respectfully with colleagues and customers.

HVAC Installation Technician

Job Description Job Description Lead HVAC Install Technician — Your Experience Matters. Your Family Does, Too. You’ve worked hard to master your trade. Join a company that values that experience, rewards quality work, and respects the family you’re working for. R&B Climate Control is a a well established, family-owned company with 20 years in Fort Mill SC that’s continuing to grow. We’re looking for experienced Lead HVAC Install Technicians to grow with us. If you take pride in your installations, lead by example, and care about doing the job right, we want to hear from you. Here, your hard work gets noticed, your leadership makes a difference, and your family’s priorities matter. \nCompany Description If you’re a top professional and want to work at a place where you are truly appreciated and respected, then we would like to sit down with you, learn what you are looking for both professionally and personally and be a part of your future. We are looking for Technicians to join our team! R&B invests in its employees and their families. Taking care of our customers starts with our employees. Leadership is is hands on with wanting you to grow and polish your skills. Company Description If you’re a top professional and want to work at a place where you are truly appreciated and respected, then we would like to sit down with you, learn what you are looking for both professionally and personally and be a part of your future. We are looking for Technicians to join our team! R&B invests in its employees and their families. Taking care of our customers starts with our employees. Leadership is is hands on with wanting you to grow and polish your skills.

HVAC Service Technician

Job Description Job Description Do you want to be part of a team where people intentionally show up for each other without hidden agendas or motives? Are you looking for an organization that is generous with praise and celebrates successes? If you answered yes to both questions, then keep reading! Generous paid time off benefits, new hires start at 104 hours of PTO 2 floating holidays, prorated based on date of hire. We have great benefits starting on your first day – check them out below! Who is MacLellan HVAC & Mechanical? MacLellan HVAC & Mechanical is a division of MacLellan Services. We provide a range of services in Industrial and Commercial settings. Our expertise includes Owner Direct Service Projects, Planned Maintenance, Equipment Service, Equipment Repair, Equipment Installation, and Facility Services. MacLellan HVAC & Mechanical is Best People, Best Systems, Best Results . We are one team. We bring people together who share our values: Trust | Integrity | Responsibility | Community | Excellence and help them discover and achieve their potential. We do this by being accountable to each other, being open to new ideas, and taking action to improve conditions, situations, and surroundings. From our Team Members to our President, everyone has a voice at MacLellan. Our team leads us and shapes our future! Who are You at MacLellan? As the HVAC Technician III, you are part of Best People. Your dedication to your craft is clear, and your willingness to help mentor junior level technicians distinguishes you . Capitalizing on your master journey-level experience as an HVAC technician III, you utilize our Best Systems, to inspect, troubleshoot, service, and repair industrial and commercial heating, ventilating, air conditioning, and refrigeration equipment and components, along with chillers, cooling towers, fans, pumps, motors, electrical controls, and associated safety and equipment protection devices. Because the HVAC Technician II is passionately committed to being the best, you engage our clients daily to grow our business relationships, using your foresight to see potential issues and by delivering timely solutions to avert those same issues to produce Best Results. What are the skills necessary for HVAC Technician III success? Excellent interpersonal and customer service skills. Excellent verbal and written communication skills. Excellent organizational skills and attention to detail. Excellent time management skills with a proven ability to meet deadlines. Ability to prioritize tasks and to delegate them when appropriate. What HVAC Technician III experience is needed for success? 10-years of progressive, professional experience performing maintenance, service and repair of HVAC systems and equipment for large industrial and commercial customers is required. HVAC contractor's license and EPA 608 Certification is preferred. What can you expect in return for your commitment to MacLellan? You can expect a culture where we make each other look great by having each other’s back. You can expect a culture where we are transparent as an organization and open with each other, always working as a team to help one another. You can expect a culture where we take our work seriously, but not ourselves. In addition to a great culture, you can expect these great benefits too! Medical, Dental, Vision, and Life Insurance Coverage begin on the first day of full-time employment Flexible Spending Accounts and Health Savings Accounts available 401(k) eligibility the first day of the month after your date of hire, 5% Company Match after 6 months of employment, Company match is immediately vested Generous Paid Time Off (PTO) program that includes personal floating holidays Paid company holidays Professional training opportunities through SECorps Association Optional Life Insurance available Weekly Pay Employee Referral Bonuses - get paid to bring your friends! Paid Volunteer Time Off (VTO) for Community Service Come join our team and let’s build something great together!