Validation Engineer - Upstream
On-site · Humacao, Humacao, Puerto Rico
Job Summary
Validation Engineer with experience in upstream equipment to validate equipment, processes, and systems in pharmaceutical/biotechnology manufacturing. Responsibilities include developing and executing validation protocols for upstream equipment (fermenters, bioreactors, centrifuges, filtration systems, chromatography), coordinating with cross-functional teams, analyzing validation test results, addressing deviations/non-conformances, and supporting continuous improvement initiatives. Requires a Bachelor's degree in Engineering, 3+ years of industry experience, familiarity with URS/DS and IQ/OQ/PQ protocols, and bilingual English/Spanish. Located in Humacao, Puerto Rico.
Required Qualifications
- Bachelor's degree in Engineering or related field
- Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries
- Proven experience as a Validation Engineer in a manufacturing environment
- Strong knowledge of upstream equipment and processes, including fermenters, bioreactors, centrifuges, filtration systems, and chromatography equipment
- Familiarity with industry regulations and standards
- Excellent problem-solving skills and attention to detail
- Effective communication skills and ability to work in a team environment
- Must be fully bilingual (English / Spanish) with excellent oral skills
- Must be proficient using MS Windows and Microsoft Office applications
- Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation
- Available to work extended hours, possibility of weekends and holidays
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