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Title: Validation Engineer
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration – Contract – 6 months+
- Pay rate: $100-115/hr.
- Job Location: Cambridge, MA
- Job#: bh12450
Provides support in the areas of commissioning and qualification of facilities, equipment, laboratory, utilities and equipment. 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.
- Author/Revise Validation SOP’s for the PVD and Cambridge Sites.
- Support harmonization of validation program at Cambridge and PVD with our SOPs.
- Assist in the investigation and remediation of Quality Events related to qualified equipment.
- Assist in managing the Requalification schedule of CAMB & PVD equipment
- 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 at Cambridge and PVD facilities.
- Participates in continuous improvement and validation maintenance efforts.
- 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 lyophilization technology 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
Bachelor’s degree in Engineering or related scientific discipline with 5 – 10 years of Pharmaceutical/Biotechnology/Device industry experience or combination of work experience in Validation, QA, MFG, or Engineering.
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