Job Description

Summary:

Commissioning and Qualification (C&Q) contracted services to support capital projects for the Engineering department of a pharmaceutical manufacturing industry in Puerto Rico.

Responsibilities: Facilities and Infrastructure Projects

• Develop and maintain project-specific commissioning plans and schedules.
• Review design documents, specifications, drawings, and user requirements to define commissioning scope.
• Support commissioning strategy development and risk assessments for each project.
• Coordinate commissioning activities with Engineering, Facilities, Validation, Quality, EHS, Operations, and contractors.
• Develop commissioning protocols, checklists, and turnover packages.
• Verify installation completion and construction readiness for commissioning.
• Perform field inspections and walkthroughs to verify installation against approved designs.
• Execute and document commissioning activities, inspections, and functional testing.
• Coordinate startup, testing, balancing, and system performance verification activities.
• Manage punch-list development, tracking, and closure.
• Coordinate commissioning issue resolution and corrective actions.
• Verify equipment and system documentation is complete, including manuals, drawings, certificates, and maintenance requirements.
• Support development of preventive maintenance and operational requirements.
• Facilitate handover of commissioned systems to Operations and Facilities teams.
• Prepare final commissioning reports and turnover documentation.
• Support qualification readiness assessments for direct impact systems where applicable.

Requirements:

• Bachelor's degree in Engineering, Biology, Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
• 3-5 years’ experience in pharmaceutical or regulated manufacturing environment; ideally, the candidate will have previous Oral Solid Dose (OSD) manufacturing experience.

Work Methodology:

• Professional services agreement (independent contractor)
• Full time job
• Full on site job in Vega Baja, Puerto Rico
• Languages: Spanish and English
• Type of industry: Pharmaceutical
• Expected hiring date: October 2026
• Project term: 12 months with potential extensions
• Amount of openings: 2
• Administrative shift, wiling to support non-admin hours