Validation Engineer - Katalyst Healthcares & Life Sciences
Cambridge, MA 02138
About the Job
Responsibilities:
- Provide validation subject matter expertise / support for equipment and systems in use at Client site which includes Analytical Instruments, Manufacturing Operation Units and CTUs (Controlled Temperature Units).
- Ensure the validated status of site facilities, utilities, equipment and processes is established and maintained in accordance with internal procedures, regulatory requirements and industry guidance / standards.
- Draft, review, approve and execute Assessments, URS, IOQ and PQ protocols and Summary Reports for Equipment and Systems.
- Maintain Periodic Review and Continuing Qualification program for existing equipment and systems.
- Provide expertise for the investigation and compliant resolution of non-conformances encountered during (re)qualification/(re)validation activities.
- Prepare protocols and reports for validation and revalidation work
- Participate in the creation and/or review of Standard Operating Procedures (SOPs) for system projects.
Requirements:
- Extensive knowledge of quality systems and performing system impact assessments.
- Knowledge in 21CFR Part 11 and Data Integrity.
- Strong understanding of validation principles including but not limited to FEU, cleaning, process and computer systems.
- Excellent technical documentation generation and review skills ensuring the content is technically sound, adheres to applicable site procedures and is suitable for regulatory submission/inspection.
- Experience using Kneat is a plus.
- Able to work effectively as a part of a cross functional team and maintain good relationships with internal and external stakeholders.
- Strong interpersonal and communication skills
- Proven ability to work independently as well as to collaborate and communicate effectively and work effectively in a team-oriented environment.
- Bachelor's degree in engineering, Science or related technical field.
- 5-7 years in CQV experience in cGMP manufacturing with experience in Analytical/Lab instruments qualification.
Source : Katalyst Healthcares & Life Sciences