Sr Engineer - 35600
On-siteJuncos, Juncos, Puerto Rico
Job Summary
Conduct comprehensive technical assessments of manufacturing equipment to evaluate performance, reliability, and operational suitability within a regulated pharmaceutical environment. Prepare, review, and approve technical reports, engineering evaluations, and supporting documentation while ensuring compliance with cGMP requirements. Evaluate equipment failures, maintenance history, and operating conditions to support deviations, investigations, CAPAs, and change controls. Collaborate with Manufacturing, Maintenance, Validation, and external vendors to analyze technical data and develop data-driven conclusions. Maintain a strong field presence by inspecting equipment and verifying actual operating conditions in manufacturing areas. Independently manage multiple assessments and deliverables while meeting project timelines.
Required Qualifications
- Bachelor's Degree in Engineering or related technical discipline
- Minimum of 4 years of engineering experience in the pharmaceutical, biotechnology, or other regulated manufacturing industry
- Experience performing technical assessments of manufacturing equipment in a regulated environment
- Strong understanding of cGMP regulations and quality system requirements
- Excellent technical writing, communication, and problem-solving skills
Desired Qualifications
- Experience supporting purification, fermentation, process equipment, utilities, or pharmaceutical manufacturing systems
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