Essential Duties and Responsibilities:
- Write and execute validation and re-validation protocols and reports, (IQ / OQ / PQ), for the validation of new and existing processes, equipment, systems, etc.
- Write summary reports, following good documentation practices.
- Use Kaye Validator to perform mapping studies.
- Write/update SOPS.
- Analyze statistical data to verify acceptable criteria.
- Develop testing strategies and rationale for equipment/systems.
- Provide technical support/troubleshooting for process and equipment issues.
- Attend production and team meetings, as required.
- Maintain close contact with manufacturing groups to assure effective communication on issues related to validation.
- Apply cGMP guidelines to all aspects of validiation.
- Investigate/resolve deviations associated with validation studies.
- Assist with commissioning, FATs and SATs.
Qualified candidates B.S. in Engineering or related science, or equivalent job experience, and have a minimum of 2 years of experience achieving competence in the above responsibilities in pharmaceutical manufacturing or comparable environment. Experience and knowledge of HVAC systems, clean rooms, sanitary processing, sterilization equipment, and WFI systems, computer control systems, cleaning processes and aseptic manufacturing is very desirable. Experience with Kaye Validator. Outstanding verbal and written communication skills. Must be able to work effectively on project teams.