Validation Engineer
On-site · Barceloneta, Barceloneta, Puerto Rico
Job Summary
Validation Engineer responsible for executing and supporting validation activities for aseptic filling lines (vial filling, stoppering, capping) and related processes, including IQ/OQ/PQ, lyophilization (if applicable), and equipment commissioning/qualification. Will generate and review validation master plans, SOPs, protocols, and final reports; ensure compliance with cGMP, FDA, EMA, and ICH guidelines; perform risk assessments (FMEA) for validation scope; support data integrity and 21 CFR Part 11 considerations; collaborate with Manufacturing, QA, Engineering, and MSAT to drive quality and regulatory compliance.
Required Qualifications
- Bachelor’s degree in Engineering, Chemistry, Biology, or related field
- 3–7+ years of validation experience in biotech or pharmaceutical industry
- Strong experience with aseptic processing, vial filling operations, sterile manufacturing environments
- Fully bilingual English/Spanish with excellent oral skills
- Proficient with MS Windows and Microsoft Office
- Strong knowledge of cGxP and regulatory guidance and application to regulatory compliance
- Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation
- Willingness to work extended hours, weekends and holidays
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