Position SummaryTechnical & Engineering Consulting LLC (Tech Eng) is seeking an experienced
Commissioning & Qualification (C&Q) Engineer to support a major utilities and equipment qualification project within a regulated biotechnology manufacturing facility in Puerto Rico.
The selected candidate will be responsible for planning, coordinating, developing, and executing commissioning and qualification activities associated with critical utility distribution systems, process equipment, and supporting infrastructure.
This position requires strong technical knowledge of commissioning and qualification methodologies, protocol execution, equipment verification, and documentation practices within a GMP-regulated environment.
Key ResponsibilitiesCommissioning & Qualification Execution- Develop, review, and execute commissioning and qualification protocols for equipment, facilities, and utility systems.
- Perform Commissioning Testing (CT), Installation Verification (IV), Installation and Operational Verification (IOV), Operational Verification (OV), and Functional Testing (FT).
- Conduct equipment and system walkdowns to verify installation, functionality, and compliance with project requirements.
- Coordinate commissioning and qualification activities with Engineering, Operations, Quality, and project stakeholders.
- Support execution readiness, including coordination of required personnel, equipment, materials, and plant resources.
- Identify, document, and escalate technical issues encountered during protocol execution.
Equipment & Utility Systems- Support commissioning and qualification activities involving:
- Boilers and master control systems.
- Turbines and duct burners.
- LNG distribution and associated utility systems.
- Process and unloading pump skids.
- Storage tanks and glycol systems.
- Pressure Regulation Systems (PRS).
- Boil-Off Gas (BOG) systems.
- Safety PLCs and control panels.
- Verify system installation and operational performance against approved engineering specifications and qualification requirements.
- Support equipment and utility system readiness for operational use.
Documentation & Compliance- Develop and maintain accurate commissioning and qualification documentation in accordance with applicable GMP requirements and site procedures.
- Review Turnover Packages (TOPs) to verify completeness and inclusion of required C&Q documentation.
- Evaluate project change controls and determine their impact on commissioning and qualification activities.
- Support documentation review, approval, and transfer to Engineering Document Management Systems (DMS) or Quality.
- Ensure protocol execution records are complete, accurate, and properly documented.
- Support timely resolution of documentation deficiencies and qualification-related issues.
Project Coordination & Execution- Participate in project meetings, technical discussions, and equipment walkdowns.
- Coordinate with Engineering, Operations, Quality, contractors, and other project stakeholders.
- Monitor assigned activities against project milestones and deliverable schedules.
- Identify potential project delays, technical challenges, and execution risks.
- Escalate issues promptly and recommend appropriate mitigation actions.
- Maintain compliance with applicable site safety policies, procedures, and GMP requirements.
Required Qualifications- Bachelor's degree in Chemical, Mechanical, Electrical, Industrial Engineering, or a related technical discipline.
- Experience in commissioning, qualification, or validation activities within pharmaceutical, biotechnology, or other regulated manufacturing environments.
- Working knowledge of GMP requirements and Good Documentation Practices (GDP).
- Experience developing, reviewing, or executing commissioning and qualification protocols.
- Ability to interpret engineering documentation, including P&IDs, equipment specifications, and technical drawings.
- Strong technical troubleshooting, analytical, and problem-solving skills.
- Excellent documentation, organization, and communication skills.
- Ability to work independently and collaborate with multidisciplinary project teams.
- Availability to work on-site in Juncos, Puerto Rico.
Preferred Qualifications- Experience supporting utilities, mechanical equipment, or process systems commissioning and qualification.
- Familiarity with LNG distribution systems, boilers, turbines, pumps, tanks, and industrial control systems.
- Experience with Installation Verification (IV), Installation and Operational Verification (IOV), Operational Verification (OV), Functional Testing (FT), and Commissioning Testing (CT).
- Experience reviewing Turnover Packages (TOPs), change controls, and technical documentation.
- Familiarity with automation systems, PLCs, and equipment control panels.
- Previous experience supporting capital projects in biotechnology or pharmaceutical manufacturing facilities.
- Bilingual proficiency in English and Spanish.
Work Environment & Project Requirements- Full-time, on-site assignment at a regulated biotechnology manufacturing facility.
- Work activities must comply with all applicable site safety requirements, GMP procedures, and project execution standards.
- Personal Protective Equipment (PPE) must be used as required by site policies and assigned activities.
- Ability to participate in equipment walkdowns and field commissioning activities.
- Flexibility to support project schedules and evolving execution priorities.
