Write and execute validation protocols for new and existing equipment, facility utilities, and manufacturing processes.
Start-up C&Q experience of process and utility systems.
Be able to work as part of a large project team and be a system owner for a system.
Role will involve authoring and executing CQV documentation for a defined system against project schedule and timelines.
Deviation/Nonconformance write up and close out resolution.
Provide direction, input, review, and approval of engineering studies, FAT, IQ, OQ, and PQ validation protocols and reports for facilities, equipment, systems, and utilities to ensure thoroughness, accuracy, and compliance with company policies.
Provide technical troubleshooting and creative solutions to manufacturing process challenges.
Qualifications, Skills, And Experience:
Bachelor’s degree (preferably in an engineering discipline) or relevant engineering, scientific or related discipline.
3+ years professional experience in biologics/pharmaceutical.
Experience developing and executing process, equipment, and cleaning validation protocols.
Knowledge of cGMP practices and standards.
Excellent written and verbal communication and interpersonal skills; prefer an individual with a positive, results-oriented, team mindset and capable of changing direction and focus as priorities shift.
Job Type: Contract
Salary: $45.00 - $50.00 per hour
- 8 hour shift
Ability to commute/relocate:
- Annapolis, MD: Reliably commute or planning to relocate before starting work (Preferred)
- Email ID -
- Visa Status/Work Authorization -
- Expected Pay Rate -
- Bachelor's (Preferred)
- Pharmaceutical: 6 years (Preferred)
- Validation Engineer (Pharmaceutical): 6 years (Preferred)
Work Location: One location