Title: Process Validation Engineer
Duration: 12+ months
Location: Massachusetts
Responsibilities:
- Write protocols for manufacturing and operations teams.
- Assist in report writing to meet client expectations.
- Conduct batch record reviews for compliance.
- Review data protocols for accuracy and regulatory alignment.
- Work within fill/finish processes and process validation to ensure product quality.
Additional Skills & Qualifications:
- Experience in a Contract Development and Manufacturing Organization (CDMO) preferred.
- Strong communication skills in a client-facing role.
- Bachelor's degree in Biochemistry, Biology, or a related field with 7-10 years of experience.
- Specific experience in fill/finish processes and process validation.