- Actalent (Winston Salem, NC)
- …, systems engineering. + Understanding of full compliance for lab instrumentation, validation protocols, FDA compliance, audit, lab equipment, IQ, OQ, PQ. ... Validation Engineer Job Description This validation Engineer...+ Audit and FDA experience. Additional Skills & Qualifications + Education in Engineering,… more
- VTI Life Sciences (Raleigh, NC)
- …and future site regulatory inspections + SME for presentation of cleaning validation to Regulatory ( FDA ), internal and external auditors. + Identify ... in the Life Sciences industry. We are looking for up to 10 Cleaning Validation Engineers to work onsite at our client's pharmaceutical manufacturing facility in the… more
- ThermoFisher Scientific (Greenville, NC)
- …Practices (GMP) Safety Standards, Office **Job Description** **Title: Engineer III, Validation ** As part of the Thermo Fisher Scientific team, you'll discover ... NC, site and will report to the Sr Manager, Validation . The Drug Product Division - North America (DPD-NA)...+ Host and coordinate regulatory inspections performed by the FDA , MCA, and other regulatory agencies. + Defend policies,… more
- Astellas Pharma (Sanford, NC)
- **Specialist, QA Validation ** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to ... visit our website at **www.astellas.com** . **The Role** The Specialist, QA Validation will be primarily responsible for the implementation, execution and assessment… more
- Biomat USA, Inc. (Research Triangle Park, NC)
- …our RTP, NC Office.** Ensures current Good Manufacturing Practices (cGMP) and FDA /Grifols Quality Systems are adhered to throughout the evaluation, review and ... approval of validation and quality assurance/control documentation. + Assists in the...procedures that relate to process, computer systems, and equipment validation . + Assures compliance with SOPs upon implementation. Investigates… more
- Stantec (Raleigh, NC)
- …the designs that support and enhance our communities. The Commissioning and Validation role provides crucial services to confirm equipment and facilities meet the ... hear from you. We have two immediate openings in our Buildings Commissioning/ Validation group for an enthusiastic, diligent and experienced Commissioning / … more
- ThermoFisher Scientific (Greenville, NC)
- …Practices (GMP) Safety Standards, Office **Job Description** **Title: Engineer II, Validation ** As part of the Thermo Fisher Scientific team, you'll discover ... NC, site and will report to the Sr Manager, Validation . The Drug Product Division - North America (DPD-NA)...and efficiencies. + Coordinate regulatory inspections performed by the FDA , MCA, and other agencies. + Defend policies, procedures,… more
- Novant Health (Charlotte, NC)
- …and compliancewith regulatory entities including FACT, CLIA, NMDP, CIBMTR, and FDA . Responsible for qualification, validation , auditing of all critical ... processes,equipment, supplies, and vendors, and proficiency testing. Facilitates creation and maintenance of critical documents such as SOPs, forms,worksheets, and product labels. Approves technical lab processes and procedures. Manages the cell lab team and… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …operations. + Experience with cGMP manufacturing environments and regulatory requirements ( FDA , EMA, ICH). + Familiarity with process validation principles ... and compliance of downstream operations through effective technology transfer, validation support, process monitoring, troubleshooting, and lifecycle management activities… more
- Gilead Sciences, Inc. (Raleigh, NC)
- …expertise in SAP BRH & SAP QM module, regulatory compliance (such as GxP and FDA ), and life sciences Quality Management and Batch Release processes. As an SAP BRH ... Sciences manufacturing operations, ensuring alignment with industry regulations such as GxP, FDA , and 21 CFR Part 11. Design scalable, efficient, and compliant… more