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