System Validation Professional
1 week ago
We are seeking a skilled professional to join our organization in an 11-month contract capacity at Pfizer's Grange Castle site. The successful candidate will be responsible for generating documentation for cGMP commissioning/qualification of systems and equipment, including CTP/IQ/OQ/PQ protocols and reports.
Key Responsibilities:- Develop and implement CTPs, IQ, OQ, PQ Protocols in the field.
- Manage system change controls and ECMs.
- Participate in design review for new/modified utility systems.
- Perform temperature mapping of equipment.
- Verify pre and post study calibration settings.
- Operate according to SOPs developed for validation, manufacturing operations, and cGMP compliance.
- Implement changes required to resolve deviations/events effectively.
- Bachelor's degree in engineering with emphasis on mechanical or process engineering.
- Minimum of 3-5 years' experience from biotechnology or pharmaceutical GMP manufacturing environment.
- Experience in temperature mapping with Lives XpertVal system is an advantage.
- Qualification of clean utilities or HVAC experience is an advantage.
- Ability to work independently and respond to business needs proactively.
- Excellent interpersonal and communication skills.
- Good documentation practices.
- Reading/verifying P&IDs experience.
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