We are looking for a proven Quality/Validation resource to join our Life Sciences team in support of a pharmaceutical client in the Boston, MA area. Successful candidates should have previous experience managing cGMP compliance of process, facility, utilities, equipment, and computer system validation.
This individual will be responsible for ensuring review and approval of all validation records and documentation (i.e. process validation, cleaning validation, computer system validation, method validation/transfer, and equipment lifecycle documentation).
Roles and Responsibilities:
- Provide QA oversight of commissioning, qualification, and validation activities to GMP manufacturing facility.
- Responsible for managing the review/approval of design and commissioning documentation, validation protocols, reports, and support records to certify compliance with specifications and procedures.
- Review and assist in investigating deviations related to manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments.
- Responsible for performing change control assessments and reviewing/approving change control implementation plans for process, equipment, utilities, and computer system validation.
- Must have strong understanding of computerized and automated systems validation engineering lifecycle.
Position Requirements and Qualifications:
- Minimum of 5+ years of Quality Assurance/Validation experience in the biotechnology or pharmaceutical industries.
- Experience in IT systems, automation, operations, and/or manufacturing within the biotechnology industry and in new manufacturing facility start-up environments is preferred.
- Must have demonstrated understanding of cGMP.
- Strong understanding of QA principles, industry practices, and standards with demonstrated ability to apply these to GMP operations is required.
- Proven ability to manage projects while meeting all deliverables and timelines.
- Strong knowledge of global regulatory requirements for validation, including current GAMP, ASTM-E2500, ICH guidelines and USP, 21CFR210, 21CFR211, and 21CFR11.
Bachelor’s Degree in Science or related technical field.