Construction & Facilities Commissioning | Pharmaceutical
About The Position
We are seeking a Construction & Facilities Commissioning Specialist to support commissioning and qualification activities for pharmaceutical manufacturing facilities in Manatí, Puerto Rico. The specialist will support commissioning, construction turnover, startup, and operational readiness activities for pharmaceutical equipment, utilities, HVAC, automation, and facility systems while ensuring compliance with cGMP requirements and company standards. The ideal candidate will have strong hands-on experience in pharmaceutical manufacturing environments, particularly sterile manufacturing and packaging areas, with experience in Facilities/Utilities Commissioning, clean utilities, HVAC, BAS/Honeywell systems, construction turnover, and startup activities. Experience with autoclave installation or commissioning and electronic validation systems such as ALM is preferred. This is a contract-based, on-site opportunity for an independent professional willing to work at the client site in Manatí, Puerto Rico.
Requirements
- Fluent in English and Spanish, spoken and written.
- Strong knowledge of cGMP regulations and pharmaceutical manufacturing requirements.
- Strong technical writing and documentation skills in English.
- Proficiency in Microsoft Office, including Word, Excel, PowerPoint, Outlook, and Teams.
- Strong attention to detail and ability to maintain accurate commissioning and technical documentation.
- Effective communication and collaboration skills.
- Ability to work independently and manage multiple priorities in a fast-paced pharmaceutical environment.
- Minimum of 5 years of experience in Facilities/Utilities Commissioning or related commissioning projects.
- Experience working in pharmaceutical product manufacturing environments, preferably in sterile manufacturing or packaging areas.
- Hands-on experience with Commissioning & Qualification of pharmaceutical facilities, utilities, equipment, and systems.
- Experience with clean utilities, including clean steam, condensate return, potable water, and compressed air.
- Experience with HVAC commissioning, including HEPA filtration and pressure control systems.
- Experience with BAS/Honeywell commissioning or similar automation platforms.
- Experience supporting construction turnover, startup, qualification readiness, and operational readiness.
Nice To Haves
- Experience with installation and/or commissioning of pharmaceutical autoclaves.
- Experience with electronic validation systems such as ALM or similar platforms is preferred.
- Experience with equipment skids, local HMIs, control panels, instrumentation, electrical systems, or equipment integration is a plus.
- Experience with facility modifications, including architectural, mechanical, electrical, and support systems, is a plus.
- Experience with one or more of the following systems is highly desirable: Equipment: PSA GMP Production Autoclave, control panels, equipment skids, local HMIs. Utilities: Clean Steam, Condensate Return, Plant Steam, Potable Water, Compressed Air, Electrical, and Instrumentation. HVAC: Room HVAC modifications, HEPA filtration, pressure control, and environmental monitoring interfaces. Automation: Honeywell Experion integration, BAS interfaces, alarm monitoring, data collection, and network interfaces. Facility Systems: Architectural modifications, mechanical systems, electrical infrastructure, and support systems serving the autoclave area.
Responsibilities
- Support and execute Commissioning & Qualification (C&Q) activities for pharmaceutical equipment, utilities, HVAC, automation, and facility systems.
- Support commissioning of clean utilities, including clean steam, condensate return, potable water, compressed air, electrical, and instrumentation systems.
- Support HVAC commissioning, including room modifications, HEPA filtration, pressure control systems, and environmental monitoring interfaces.
- Support BAS/Honeywell commissioning, including alarm monitoring, data collection, network interfaces, and equipment integration.
- Support commissioning and installation activities for pharmaceutical autoclaves, associated control panels, equipment skids, and local HMIs.
- Support construction turnover, startup, qualification readiness, and operational readiness activities.
- Prepare, review, and execute commissioning and qualification documentation and test protocols.
- Support electronic protocol execution and documentation using ALM or similar electronic validation systems.
- Collaborate with Engineering, Validation, Quality, Manufacturing, Facilities, Utilities, Automation, Construction, and vendors to support successful project execution.
- Ensure commissioning activities and documentation comply with cGMP requirements, company procedures, and quality standards.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
