Senior Equipment Assessment Engineer - Biopharma (On-site PR)

Biopharma-Consulting-Jad-Group; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Biopharma-Consulting-Jad-Group seeks a Senior Engineer to support Drug Substance Facilities and Engineering at a biopharmaceutical manufacturing site in Juncos, Puerto Rico. This role independently performs technical assessments of manufacturing equipment and systems, and applies advanced engineering principles to process optimization, troubleshooting and system modifications of significant scope.

Responsibilities include preparing and reviewing technical reports, evaluating equipment

Qualifications

• Experience performing technical assessments of equipment in a regulated pharma/biotech environment.
• Experience with purification, fermentation, process equipment, utilities or pharmaceutical manufacturing systems.
• Strong knowledge of cGMP and validation requirements; inspection-ready documentation.
• Strong field presence and willingness to inspect equipment in manufacturing areas.

Responsibilities

• Prepare, review and approve technical reports, engineering assessments, equipment evaluations and technical justifications.
• Evaluate equipment failures, performance issues, maintenance history and operating conditions, and their potential impact on product, process, quality and qualified state.
• Provide technical support for deviations, investigations, CAPAs, change controls, risk assessments and regulatory commitments.
• Assess equipment design, reliability, lifecycle documentation and maintenance strategies for continued fitness for use.
• Review engineering drawings, specifications, vendor documentation, work orders, calibration records and historical performance data.
• Collaborate with Manufacturing, Maintenance, Automation, Validation, Quality, Process Development and vendors.
• Develop technical solutions to complex problems and coordinate the work of engineers, consultants and vendors as needed.

Skills

Technical writing

Problem solving

Communication

Project management

Education

Doctorate

Master’s + 2 years

Bachelor’s + 4 years

Job description

Biopharma-Consulting-Jad-Group seeks a Senior Engineer to support Drug Substance Facilities and Engineering at a biopharmaceutical manufacturing site in Juncos, Puerto Rico. This role independently performs technical assessments of manufacturing equipment and systems, and applies advanced engineering principles to process optimization, troubleshooting and system modifications of significant scope.

Responsibilities include preparing and reviewing technical reports, evaluating equipment