Sr Engineer - Equipment Technical Assessments

Biopharma-Consulting-Jad-Group; Juncos (PR); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Technical writing

Problem solving

Communication

Project management

Ausbildung

Doctorate

Master’s + 2 years

Bachelor’s + 4 years

Jobbeschreibung

We are seeking 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 and complexity.

Key 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.

Education (one of the following)

• Doctorate degree; OR
• Master's degree + 2 years of engineering experience; OR
• Bachelor's degree in Engineering + 4 years of engineering experience

Preferred Qualifications

• Experience performing technical assessments of equipment in a regulated pharmaceutical or biotechnology manufacturing 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

Key Skills

• Strong technical writing, problem-solving and communication skills
• Ability to independently manage multiple assessments and deliverables
• Collaboration, facilitation and basic project management
• Management of contractors and vendors

• Contract position: approximately 12 months (through September 2027), with possible extension
• Shift: Administrative shift
• Days: Monday to Friday, 8 hours/day (40 hours/week)
• On-site in Juncos, Puerto Rico