Construction & Facilities Commissioning | Pharmaceutical

LOCATION:
Manatí, Puerto Rico

Job Description
We are seeking a Construction & Facilities Commissioning Specialist to support projects within a pharmaceutical manufacturing environment in Manatí, Puerto Rico. This role will focus on facility and utility commissioning, construction turnover, startup, and operational readiness, ensuring activities are executed in accordance with cGMP requirements and company standards. The ideal candidate will have hands-on experience in sterile manufacturing or packaging environments, with a strong background in clean utilities, HVAC, BAS/Honeywell systems, and facility-related projects. 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 Main 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. General 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. Education Requirements
- Bachelor’s Degree in Engineering, Life Sciences, or a related technical field preferred. Experience Requirements
- 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.
- Preferred: 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. Systems in Scope 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. Physical Requirements
- Ability to work on site in Manatí, Puerto Rico.
- Ability to work in pharmaceutical manufacturing, construction, and industrial environments.
- Ability to access manufacturing and field areas as required.
- Ability to wear required personal protective equipment (PPE).
- Ability to stand, walk, and perform light physical activities as required in field and manufacturing areas.