Equipment Validation Engineer
3 days ago
Qualifications:
- Bachelor's degree in Engineering or related field
- 3+ years of validation experience in a cGMP environment, supporting equipment qualification and facilities commissioning activities
- Knowledge of validation software systems: Kneat
Pluses:
- Master's Degree Engineering or related field
Responsibilities:
A pharmaceutical company in the Raleigh, NC area is looking for an Equipment Validation Engineer to join their growing team. This person will be responsible for:
- Providing support for autoclaves, isolators, parts washers, decontamination area, etc
- Generates operational protocol(s), qualification IQ, OQ, PQ protocols and SOPs for various equipment/systems/processes in the facility
- Author/review executed equipment qualification protocols and summary report
- Drive planning activities
- Assist with the execution of equipment qualification protocols
- Provide hands on support to the manufacturing areas as required to assist in problem solving and long-term changes that provide product/process improvements in relation to equipment failures; Collect and analyze data to make data driven recommendations/decisions
- Production oversight during validation events
- Provide qualification support for systems as assigned.
- Work on other projects and tasks as needed to support the site.
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