Validation Specialist, Quality Assurance

Astellas Institute for Regenerative Medicine seeks Validation Specialist, Quality Assurance in Westborough, MA

Duties:

1. Provide commissioning, qualification and validation (CQV) support to a CGMP Cell Therapy Manufacturing plant.

2. Support CQV mission to ensure that all critical Good Manufacturing Practices (GMP) equipment and systems are validated and maintained in compliance with user requirements, process parameters and global regulatory guidelines.

3. Author technical documents such as protocols, reports, user requirements statements, deviations and risk assessments.

4. Write, execute and approve equipment validation protocols and reports following good documentation practices.

5. Interface with system owners, IT and facilities engineering to ensure all user and compliance requirements are tested as well as support the creation of the requirements for new equipment or products.

6. Evaluate vendor qualification packages and create wrappers as necessary.

7. Generate, execute and review completed qualifications and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.

8. Maintain close contact with manufacturing, facilities and laboratory departments to assure effective communication on issues related to validation and the validated state of equipment and endure effective communication on validation issues.

9. Perform periodic review of equipment and systems.

10. Develop testing strategies and rationale for equipment/systems.

11. Provide technical or investigational support in troubleshooting and resolving validated equipment or system issues.

12. Serve as Subject Matter Expert for temperature mapping validation equipment and software.

Rate of Pay: $91,740.22 per year.

Email resume to: ... and reference 20357.481.4. EOE: M/F/D/V

Employer will accept a Bachelor's degree or foreign equivalent in Engineering, Life Sciences or related field and two years of experience in the job offered or in a related occupation.