Senior Engineer - GMP Process & Validation (Onsite, PR)

ProQuality Network; Juncos (PR); On-site; USD 85,000 - 125,000; Full time

Job summary

ProQuality Network in Juncos, Puerto Rico, is seeking a Senior Engineer to lead process optimization, troubleshoot operations, and manage capital projects within a regulated manufacturing environment.

The ideal candidate will apply advanced engineering principles, support equipment and process design, execute validation activities, and manage projects involving operations, manufacturing, pilot plant, or capital projects.

Qualifications

• Bachelor’s degree in Engineering with 4+ years of engineering experience, or equivalent education and experience.
• Master’s degree plus 2 years of engineering experience, or Doctorate in a relevant field.
• At least 5 years of engineering experience preferred.
• Experience in pharmaceutical, biotechnology, or medical device manufacturing preferred.
• Bilingual in English and Spanish preferred.

Responsibilities

• Lead complex or novel engineering assignments and develop improved engineering techniques, procedures, and solutions.
• Characterize process optimization strategies and troubleshoot complex operational issues.
• Apply advanced engineering principles to manufacturing processes, equipment, system modifications, experiments, and capital projects.
• Develop technical solutions to complex problems using engineering analysis, calculations, scientific principles, and creative problem-solving.
• Evaluate technical issues and independently determine when additional internal or external resources are required.
• Provide solutions to technical problems of moderate to large complexity and scope.
• Serve as a technical resource in areas of engineering expertise and establish appropriate methodologies.
• Develop requirements and engineering recommendations for major or complex system and facility modifications.
• Collaborate with Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, Validation, Research, and other cross-functional teams.
• Partner with project managers to deliver engineering projects within established schedule, budget, and quality requirements.
• Coordinate consultants, architects, engineering firms, contractors, and vendors as needed.
• Support development of standard design documents and technical requirements.
• Develop project schedules, budgets, and cost estimates involving multiple disciplines.
• Manage multiple projects simultaneously while maintaining appropriate follow-up and completion.
• Support and execute validation activities for new equipment installations and process modifications.
• Develop and review validation protocols and related technical documentation.
• Ensure engineering activities and documentation comply with applicable GMP, GLP, and regulatory requirements.
• Interpret and apply validation requirements throughout equipment and process implementation.
• Prepare technical reports, presentations, and documentation to communicate project findings and recommendations.
• Coordinate and review the work of engineers, associates, technicians, and project team members.
• Delegate and manage project activities while ensuring timely completion and follow-up.
• Provide technical leadership and facilitate collaboration across multiple functional areas.
• Support negotiation, conflict resolution, and alignment among internal teams, contractors, vendors, and other stakeholders.
• Manage contractors and vendors to support project objectives.
• Develop and maintain effective working relationships across different communication and working styles.

Skills

Bilingual English Spanish

Problem solving

Analytical thinking

Project management

Cross-functional collaboration

Education

Bachelor’s degree in Engineering or equivalent

Master’s degree with 2+ years experience

Doctorate in relevant field

5+ years engineering experience preferred

Pharma/biotech/medical devices experience preferred

Tools

Packaging equipment

Equipment validation

Capital projects

Process validation

GMP/GLP knowledge

Job description

ProQuality Network in Juncos, Puerto Rico, is seeking a Senior Engineer to lead process optimization, troubleshoot operations, and manage capital projects within a regulated manufacturing environment.

The ideal candidate will apply advanced engineering principles, support equipment and process design, execute validation activities, and manage projects involving operations, manufacturing, pilot plant, or capital projects.