View all jobs
Validation Engineer II - capital projects
Summary:
Commissioning and Qualification (C&Q) contracted services to support capital projects for the Engineering department of a pharmaceutical manufacturing industry in Puerto Rico.
Responsibilities:
Commissioning and Qualification (C&Q) contracted services to support capital projects for the Engineering department of a pharmaceutical manufacturing industry in Puerto Rico.
Responsibilities:
- Support the execution of commissioning, qualification, and validation activities for manufacturing equipment, facilities, utilities, and computerized systems.
- Assist with the development, review, and execution of qualification and validation documentation, including Validation plans, Risk assessments, Commissioning documents, IQ, OQ, and PQ protocols, Test scripts, Final reports
- Participate in protocol execution activities, including:
- Data collection and documentation
- Equipment testing and verification
- Utility and environmental monitoring support
- Sample collection
- Recording and compilation of results
- Analyze test data, identify discrepancies, and assist in troubleshooting qualification and validation issues under the direction of senior personnel.
- Maintain validation documentation and ensure records are complete, accurate, and compliant with data integrity requirements.
- Bachelor's degree in Engineering, Biology, Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
- 0-3 years’ experience in pharmaceutical or regulated manufacturing environment; ideally, the candidate will have previous Oral Solid Dose (OSD) manufacturing experience.
- Professional services agreement (independent contractor)
- Full time job
- Full on site job in Vega Baja, Puerto Rico
- Languages: Spanish and English
- Type of industry: Pharmaceutical
- Expected hiring date: August 2026
- Project term: 6-12 months with potential extensions
- Amount of openings: 4
- Administrative shift, wiling to support non-admin hours