Temporary Senior Validation Engineer
About the Job
Provides expertise, consultation, and QA support in the areas of commissioning and qualification of facilities, equipment, laboratory, utilities and equipment. Provide support to the QA Validation group in establishing a robust validation program for the maintenance of qualified facility, equipment, laboratory, instrument, utilities. Expected to work independently with minimal guidance and demonstrate the ability to multi-task, problem solve, and communicate effectively and efficiently in a dynamic and challenging environment.
- Conducts Gap Assessments of the following for adherence to regulatory requirements:
- Validation program & lifecycle
- Validation Master Plan
- Validation documentation (protocols/reports)
- Requalification program
- Propose remediation to identified gaps.
- Initiate and Own CAPA’s to remediate gaps.
- Author/Revise Validation Plans
- Author/Revise Validation SOP’s
- Support harmonization of validation program with Vertex SOPs.
- Assist in the investigation and remediation of Quality Events related to qualified equipment.
- Assist in managing the Requalification schedule
- Review lifecycle documents such as Impact Assessments, User Requirements, Design Documents, Risk Traceability Matrix, Criticality Assessments, Risk Assessments, Part 11 Assessments, etc.
- Review and Approve Validation plans, protocols and reports.
- Assess Change Controls for Validation Impact.
- Collaborates with stakeholders, engineers, SMEs, and cross functional team members in equipment qualification efforts.
- Participates in continuous improvement and validation maintenance efforts.
- Bachelor’s degree in Engineering or related scientific discipline with 8 – 12 years of Pharmaceutical/Biotechnology/Device industry experience or combination of work experience in Validation, QA, MFG, or Engineering.
- Experience in pharmaceutical or biopharmaceutical/biotechnology cGxP environment. Combination of equipment qualification, process validation, computer systems, cleaning, and sterilization is acceptable. QA pharmaceutical experience is also preferred.
- Quality experience with in-depth knowledge of Validation approach, cGxP standards and Risk based validation.
- Working knowledge of pharmaceutical and medical device facilities, equipment and clean room facilities, clean utilities and aseptic fill finish.
- Must have direct experience in the commissioning, qualification and validation of facilities, utilities, production, laboratory and support equipment.
- Experience working in cell and gene therapy products is a plus.
- Knowledge of Industry guidelines (ISPE, PDA) US and international regulations (FDA, cGMP, ICH, ISO, EMA) for validation of GMP facilities.
- Must have strong verbal, written and interpersonal communication skills, especially needed to work in a cross-functional