Utilities CQV Engineer
Your role will be to implement the commissioning and qualification of new/modified clean utilities and non GMP utilities and controlled environmental devices sitewide. The job holder will provide technical expertise to ensure that systems and equipment are installed, commissioned and qualified to Pfizer’s and regulatory specifications.
Within this role you will:
- Generate documentation for cGMP commissioning/qualification of systems and equipment, including CTP/IQ/OQ/PQ protocols and reports.
- Raise and Implement system change controls and ECM’s.
- Participate in design review for new/ modified utility systems.
- Participate in construction system mechanical completion walkdowns.
- Perform execution of CTPs, IQ, OQ, PQ Protocols in field.
- Perform execution of temperature mapping of equipment.
- Perform pre and post study calibration verifications.
- Operate according to SOPs developed for validation, validated manufacturing operations and cGMP compliance.
- Develop and implement changes required to resolve deviations/ events effectively.
To be successful in this role you will require:
- B.Sc/B.Eng. degree in engineering discipline, with particular emphasis on mechanical or process engineering.
- Minimum of 1 years’ experience from biotechnology or pharmaceutical GMP manufacturing environment.
- Demonstrated ability to work on own initiative and proactively respond to business needs.
- Excellent interpersonal and communication skills.
- Experience in good documentation practice.
- Experience in reading/verifying P&IDs.
- Experience in temperature mapping with lives xpertval system is an advantage.
- Experience with qualification of clean utilities or HVAC is an advantage.