Responsibilities:

1. Continuously evaluate and evolve Validation Policy and Procedural level documents to ensure compliance with current regulatory (FDA, etc.) expectations.
2. Serve as internal expert on validation in support of partner and regulatory audits.
3. Support/lead technical investigations.
4. Perform internal systems and compliance audits.
5. Create, revise, review and approve documentation in Quality Assurance systems, including SOPs, Validation Plans and Protocols, Risk Assessments, Investigations, Change Controls, Deviations, and CAPAs.
6. Partner closely and seamlessly across all departments to enable the entire team’s mutual growth, development, and overall success.

Requirements:

1. BS degree in Engineering or Science and/or equivalent combination of education and experience required.
2. 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.
3. Experience developing and executing validation strategies for multiple phases of clinical and commercial development required in either biotechnology, pharmaceuticals, or medical device industries.
4. Experience with new product introduction is preferred.
5. 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.).
6. Effective communication skills.
7. Ability to work in a fast-paced environment.