C&Q Program Lead

Technical & Engineering Consulting•Carolina, PR

5d•Hybrid

About The Position

Technical & Engineering Consulting LLC (Tech Eng) is seeking an experienced Commissioning & Qualification (C&Q) Program Lead to support a major pharmaceutical or biotechnology capital project in Puerto Rico. The C&Q Program Lead 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. The role combines technical C&Q expertise, capital project execution, cross-functional leadership, contractor coordination, and project management to ensure safe, compliant, and timely execution. The role is initially hybrid or remote for six months, followed by 100% on-site work in Puerto Rico. Occasional travel to vendor facilities may be required for Factory Acceptance Testing (FAT). The position is a full-time contract with an anticipated initial term of six months and an extension anticipated. The schedule is Monday through Friday, 40 hours per week, with an ASAP start date.

Requirements

Bachelor's degree in Engineering, Science, or a related technical discipline.
Minimum 10 years of experience in Commissioning & Qualification (C&Q), preferably in 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.
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.
Ability to work full-time, 40 hours per week, and on-site in Puerto Rico after the initial six-month period.

Nice To Haves

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.

Responsibilities

Lead and oversee C&Q activities across multiple project nodes, aligned with program objectives, schedules, and quality standards.
Develop and implement 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.
Coordinate commissioning and qualification activities for facilities, utilities, process equipment, manufacturing systems, and supporting infrastructure.
Oversee mechanical completion acceptance and coordinate resolution of outstanding punch-list items.
Support pre-commissioning activities, including utility priming, instrument calibration, automation downloads, consumables installation, and VFD setup.
Coordinate Factory Acceptance Testing 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 activities with appropriate teams.
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 on progress, issues, change management, and resource requirements.
Collaborate with Engineering, Construction, Automation, Quality, Manufacturing, and external service providers to support integrated project execution.
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 project nodes.
Promote a strong safety culture and ensure compliance with site safety requirements and industry best practices during commissioning, qualification, and start-up.