C&Q Program Lead – Pharmaceutical / Biotechnology

Location: 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 Overview

Technical & 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 Responsibilities

C&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.

About Technical & Engineering Consulting LLC

Technical & Engineering Consulting LLC (Tech Eng) provides specialized engineering, technical consulting, and professional staffing solutions to the pharmaceutical, biotechnology, medical device, and manufacturing industries.

We connect experienced technical professionals with challenging projects that support operational excellence, regulatory compliance, and successful capital project execution.

Join our team and contribute to a major pharmaceutical / biotechnology capital project in Puerto Rico.

Apply Today!