QA Validation Specialist
3 weeks ago
- Managing Quality Engineering and Validation (QEV) Validation programs for the facilities, utilities, manufacturing and QC lab equipment, computerized systems and associated processes.
- Responsible for maintaining and ensuring site compliance to corporate policies and procedures for the validation of systems.
- Perform Validation Risk assessments and Data Integrity evaluations in support of Validation Lifecycle Management (VLM) of equipment, facilities, utilities, processes.
- Ensure Qualification/Validation activities are completed in accordance with project timelines.
- Support enterprise, cross functional, and validation activities, in providing approach, methodology, and deliverables in compliance with 21 CFR Part 11, 58, 210 and 211, Eudralex regulations and ICH guidelines
- Define the validation strategy and associated project plan for systems at JEB and work with the applicable stakeholders to implement and then execute.
- Oversee future validation efforts associated with the operation of all GMP manufacturing systems, equipment and computer systems. Perform SDLC validation planning for each computerized system to ensure complete, successful end-to-end qualification of electronic systems, including system interfaces and infrastructure usage.
- Provide oversight to the overall computer system validation master plan, including interactions with other Just-Evotec entities responsible for related non-site-based computer systems.
- Build, teach, and act as a resource for a team of Quality Engineers with varying experience Levell
-
QA Specialist
2 days ago
Holly Springs, United States PharmEng Technology Americas Full timeJob DescriptionJob DescriptionQA Specialist PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on...
-
QA Specialist
1 month ago
Holly Springs, United States PharmEng Technology Americas Full timeJob DescriptionJob DescriptionQA Specialist PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on...
-
Specialist II/III,
1 month ago
Holly Springs, United States Seqirus U.S.A. Inc. Full timeSpecialist II/III, (Validation) - Cleaning page is loaded **Specialist II/III, (Validation) - Cleaning** **Specialist II/III, (Validation) - Cleaning** locationsSeqirus USA - NC - Holly Springs time typeFull time posted onPosted Yesterday job requisition idR-147968 **Job Purpose:** Provides validation lifecycle of processes including: Process validation,...
-
Instrumentation Specialist
1 week ago
Holly Springs, United States FUJIFILM Diosynth Biotechnologies Full timeExecute the qualification, routine operation, maintenance, continuous improvement and decommissioning of QC analytical instrumentation.Ensure all QC equipment and instruments adhere to regulatory guidelines and site policies.Author and review SOPs, technical reports, user requirements and functional specifications, and KNEAT protocols and reports.Support...
-
Instrumentation Specialist
1 week ago
Holly Springs, United States FUJIFILM Diosynth Biotechnologies Full timeExecute the qualification, routine operation, maintenance, continuous improvement and decommissioning of QC analytical instrumentation.Ensure all QC equipment and instruments adhere to regulatory guidelines and site policies.Author and review SOPs, technical reports, user requirements and functional specifications, and KNEAT protocols and reports.Support...
-
Instrumentation Specialist
1 week ago
Holly Springs, United States FUJIFILM Diosynth Biotechnologies Full timeExecute the qualification, routine operation, maintenance, continuous improvement and decommissioning of QC analytical instrumentation.Ensure all QC equipment and instruments adhere to regulatory guidelines and site policies.Author and review SOPs, technical reports, user requirements and functional specifications, and KNEAT protocols and reports.Support...
-
Quality Assurance
30 minutes ago
Excelsior Springs, United States Winland Foods, Inc. Full timeThe Quality Assurance Supervisor is responsible for ensuring timely and effective implementation of all company's policies, procedures, and activities involved in assuring the safety and quality of manufactured products. The Supervisor maintains close working relationships with other department managers and supervisory personnel in order to consistently meet...
-
QC Sr. Specialist 1, Instrumentation
1 day ago
Holly Springs, United States FUJIFILM Diosynth Biotechnologies Full timeOverview Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO The work we do at FDB has never been more important-and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to...
-
QC Sr. Specialist 1, Instrumentation
14 hours ago
Holly Springs, United States FUJIFILM Full timeFollow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMOThe work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real...
-
Fiber Splicer Technician
4 hours ago
Bonita Springs, United States Cable Wiring Specialist Full timeJob DescriptionJob DescriptionSalary: $12.00-15.00 HrCable Wiring Specialist, Inc. (CWSI) provides a large suite of construction and engineering services to the cable and Fiber Optic communications industry. With a large workforce and fleet located throughout Florida, communications corporations continue to choose CWSI for our workforce, knowledge and...
-
Holly Springs, United States UNC Health Full timeBecome part of an inclusive organization with over 40,000 diverse employees, whose mission is to improve the health and well-being of the unique communities we serve. This position will be Monday-Friday, from 7:30am-4pm. Summary: This role is responsible in ensuring that patient access processing is performed in accordance with procedure and documented in a...
-
Holly Springs, United States MMR Consulting Inc Full timeBiopharmaceutical - SENIOR COMMISSIONING & QUALIFICATION ENGINEER Previous Pharmaceutical/Biotech experience is mandatory for this role. MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services. MMRs Engineering...
-
Holly Springs, United States MMR Consulting Full timeBiopharmaceutical - SENIOR COMMISSIONING & QUALIFICATION ENGINEERPrevious Pharmaceutical/Biotech experience is mandatory for this role.MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services. MMR’s Engineering...
-
Holly Springs, United States MMR Consulting Full timeBiopharmaceutical - SENIOR COMMISSIONING & QUALIFICATION ENGINEERPrevious Pharmaceutical/Biotech experience is mandatory for this role.MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services. MMR’s Engineering...
-
Specialist IS Business Systems Analyst
22 hours ago
Holly Springs, Georgia, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
Specialist IS Business Systems Analyst
1 hour ago
Holly Springs, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
Specialist IS Business Systems Analyst
19 hours ago
Holly Springs, Georgia, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading...
-
Specialist IS Business Systems Analyst
54 minutes ago
Holly Springs, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s...
-
Commercial HVAC Specialist
4 days ago
Mount Holly, United States Boxman Studios Full timeJob DescriptionJob DescriptionJob Title: Commercial HVAC Specialist - Sheet Metal Fabricator Job Overview:Join Boxman Studios, a rapidly growing company, as an HVAC Specialist and Sheet Metal Fabricator. If you're a seasoned professional with at least 2 years of HVAC experience and are eager to advance your career while contributing innovative ideas to...
-
Behavioral Support Specialist
1 day ago
Mount Holly, United States Oaks Integrated Care Inc. Full timeJoin our team today and immerse yourself in a rewarding career for years to come! As a Behavioral Support Specialist, you will work within our adult partial care programs located throughout Southern New Jersey. Schedule: Full-time; Mon - Fri: 8:00AM to 4:30PM Competencies: The potential employee should have excellent interpersonal skills and the ability...