C&Q Program Lead - Pharmaceutical / BiotechnologyLocation: Puerto Rico (Hybrid / Remote Initially; On-Site After 6 Months)
Employment Type: Contract - Initial 6 Months (Extension Anticipated)
Schedule: Full-Time | Monday-Friday | 40 Hours per Week
Start Date: ASAP
Position OverviewTechnical & Engineering Consulting LLC (Tech Eng) is seeking an experienced
Commissioning & Qualification (C&Q) Program Lead to support a major pharmaceutical / biotechnology capital project in Puerto Rico.
The selected professional will serve as the primary technical leader for the C&Q Program, overseeing commissioning and qualification activities across multiple project nodes, facilities, utilities, manufacturing systems, equipment, and supporting infrastructure.
This role requires a strong combination of
technical C&Q expertise, capital project execution, cross-functional leadership, contractor coordination, and project management capabilities to ensure safe, compliant, and timely execution of commissioning and qualification activities.
Key ResponsibilitiesC&Q Program Leadership & Execution- Lead and oversee C&Q activities across multiple project nodes, ensuring alignment with overall program objectives, schedules, and quality standards.
- Develop and implement comprehensive C&Q strategies, execution plans, schedules, and qualification approaches.
- Provide technical direction and oversight to C&Q Node Leads, engineering teams, contractors, and external C&Q firms.
- Ensure timely development, review, and execution of C&Q deliverables in compliance with applicable regulatory requirements.
- Identify opportunities to improve C&Q execution efficiency, standardization, and program performance.
Commissioning, Qualification & System Readiness- Coordinate commissioning and qualification activities for facilities, utilities, process equipment, manufacturing systems, and supporting infrastructure.
- Oversee mechanical completion (MC) acceptance and coordinate resolution of outstanding punch-list items.
- Support pre-commissioning activities, including utility priming, instrument calibration, automation downloads, installation of consumables, and Variable Frequency Drive (VFD) setup.
- Coordinate Factory Acceptance Testing (FAT) activities with vendors, construction managers, and engineering teams.
- Support system readiness, qualification execution, and formal system handover to the end-user organization.
- Coordinate utility demands, temporary power requirements, wastewater discharge, and Lockout/Tagout (LOTO) activities with the appropriate teams.
Project Coordination & Performance Management- Coordinate day-to-day C&Q activities across multiple workstreams and project nodes.
- Monitor C&Q execution progress, resource allocation, project milestones, and critical-path activities.
- Develop and communicate progress metrics, two-to-four-week look-ahead schedules, and risk assessments.
- Identify and mitigate technical, operational, and scheduling risks affecting C&Q execution and start-up readiness.
- Provide regular program updates to senior leadership, including progress, issues, change management, and resource requirements.
- Collaborate with Engineering, Construction, Automation, Quality, Manufacturing, and external service providers to ensure integrated project execution.
Quality, Compliance & Safety- Ensure C&Q activities comply with applicable cGMP requirements, approved procedures, and project quality standards.
- Maintain consistency in C&Q strategies, documentation, and execution practices across all project nodes.
- Promote a strong safety culture throughout commissioning, qualification, and start-up activities.
- Ensure compliance with site safety requirements and industry best practices.
Required Qualifications- Bachelor's degree in Engineering, Science, or a related technical discipline.
- Minimum 10 years of experience in Commissioning & Qualification (C&Q), preferably within pharmaceutical or biotechnology manufacturing environments.
- Demonstrated experience leading C&Q teams and coordinating complex commissioning and qualification activities.
- Strong technical knowledge of pharmaceutical facilities, utilities, manufacturing equipment, and supporting systems.
- Experience developing and executing C&Q strategies, plans, protocols, and associated deliverables.
- Knowledge of applicable regulatory requirements and industry standards for commissioning and qualification.
- Proven ability to coordinate multidisciplinary teams, contractors, and engineering service providers.
- Strong project execution, problem-solving, organizational, and communication skills.
- Ability to communicate project progress, technical issues, risks, and mitigation plans to program leadership.
- Strong commitment to safety, quality, and regulatory compliance.
Preferred Qualifications- Experience supporting C&Q activities in Active Pharmaceutical Ingredient (API) manufacturing facilities.
- Experience leading or coordinating C&Q activities across multiple facilities, systems, or workstreams within large-scale capital projects.
- Experience with mechanical completion, pre-commissioning, FAT coordination, punch-list management, and system turnover.
- Experience managing integrated C&Q schedules, critical-path activities, resource planning, and performance metrics.
- Master's degree in Engineering, Science, Management, or a related discipline.
Work Arrangement- Initial six-month period: Hybrid / Remote.
- Following the initial period: 100% on-site in Puerto Rico.
- Occasional travel to vendor facilities may be required for Factory Acceptance Testing (FAT).
- Full-time commitment of 40 hours per week.
