Accentuate Staffing is partnering with a rapidly growing biotechnology company who is hiring for a Quality Engineer with a clearly demonstrated background in validation. This is a direct hire opportunity!
- Continuously evaluate and evolve Validation Policy and Procedural level documents to ensure compliance with current regulatory (FDA, etc.) expectations.
- Serve as internal expert on validation in support of partner and regulatory audits.
- Support/lead technical investigations.
- Perform internal systems and compliance audits.
- Create, revise, review and approve documentation in Quality Assurance systems, including SOPs, Validation Plans and Protocols, Risk Assessments, Investigations, Change Controls, Deviations, and CAPAs.
- Partner closely and seamlessly across all departments to enable the entire team’s mutual growth, development, and overall success.
- BS degree in Engineering or Science and/or equivalent combination of education and experience required.
- 3 (Three) up to 7 (Seven) or more years of related professional experience in a current Good Manufacturing Practices (cGMP) environment with progressive responsibilities in the validation area.
- Experience developing and executing validation strategies for multiple phases of clinical and commercial development required in either biotechnology, pharmaceuticals, or medical device industries.
- Experience with new product introduction is preferred.
- Experience in the areas of Validation (Risk Assessment, Gap Assessment, IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc.), and Process Excellence Methodologies (Six-Sigma, Lean, etc.).
- Effective communication skills.
- Ability to work in a fast-paced environment.