EDUCATION: Bachelors in Engineering + 4 years of Engineering experience.
QUALIFICATION:
Preferred candidate should have experience performing technical assessments of equipment in a regulated pharmaceutical or biotechnology manufacturing environment. Experience should include:
- Preparation, review, and approval of technical reports, engineering assessments, equipment evaluations, and technical justifications.
- Evaluation of equipment failures, performance issues, maintenance history, operating conditions, and potential impact to product, process, quality, and equipment qualified state.
- Technical support for deviations, investigations, CAPAs, change controls, risk assessments, and post-FDA commitments.
- Assessment of equipment design, functionality, reliability, lifecycle documentation, maintenance strategies, and continued fitness for intended use.
- Review and interpretation of engineering drawings, technical specifications, vendor documentation, equipment manuals, work orders, calibration records, and historical performance data.
- Development of clear, factual, and scientifically justified conclusions and recommendations based on available evidence.
- Experience collaborating with Manufacturing, Maintenance, Automation, Validation, Quality, Process Development, and external vendors to obtain and evaluate technical information.
- Knowledge of cGMP requirements and the ability to ensure that technical assessments are complete, traceable, inspection-ready, and supported by objective evidence.
- Strong technical writing, problem-solving, and communication skills, with the ability to independently manage multiple assessments and deliverables.
- Experience with purification, fermentation, process equipment, utilities, or pharmaceutical manufacturing systems is preferred.
- Strong field presence and willingness to inspect equipment and verify actual operating conditions within manufacturing areas.
SHIFT: Adminsitrative
Pay: $45.00 - $50.00 per hour
Application Question(s):
- Available for work in Juncos PR?
Education:
Experience:
- Process engineering: 4 years (Required)
Language:
- Fully Bilingual (English & Spanish) (Required)
Work Location: In person
