Lead C&Q Engineer - Clean & Dirty Utilities in Richmond, Virginia at Valsource

Position Details:

ValSource is looking to hire an experienced Commissioning & Qualification (C&Q) Lead for Clean and Dirty Utilities across multiple building on a greenfield project in the Richmond, VA area.

• Work Location: Hybrid/remote for the first six months, transitioning to 100% on-site thereafter.
• Expected Work Hours: 40 hours per week.
• Travel Requirements: Occasional travel to vendor sites for Factory Acceptance Testing (FATs), lessons-learned visits, and other project-related activities.

Overview:

C&Q Utility System Lead to support the start-up, commissioning, and qualification of clean and non-clean (dirty) utility systems. The resource will provide technical leadership and oversight for all systems, subsystems, equipment packages, utility interfaces, automation dependencies, and associated C&Q deliverables from Design Development through Commissioning and completion of Performance Qualification (PQ), where applicable.

The primary focus of this role will be on design reviews, design qualification, start-up and shake-down strategy, execution planning, and commissioning readiness. Approximately 80% of the effort will be dedicated to start-up strategy and execution, pre-execution documentation, planning, sequencing, and commissioning, with the remaining 20% focused on qualification documentation, execution, and final reporting.

The successful candidate will provide hands-on technical field support while leading the planning, staffing, coordination, and execution of Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), start-up, commissioning, and C&Q activities through final system close-out. Responsibilities will include scope definition, strategy development, schedule and resource management, risk assessment, technical decision-making, quality oversight, and execution readiness.

The C&Q Utility System Lead will work closely with engineering, automation, quality, design, construction, equipment vendors, operations, maintenance, project controls, and system owners to ensure utility systems are delivered safely, efficiently, and in compliance with project requirements, applicable regulations, and quality standards. The role requires a strong combination of utility systems expertise, commissioning and start-up experience, C&Q knowledge, field leadership, and the ability to deliver compliant, inspection-ready systems.

Primary Roles and Responsibilities:

• Own the complete end to end C&Q scope for Clean Utilities (including but not limited to Purified Water, Water for injection, Clean Steam, N2/O2/CO2, generation and distribution systems), including all associated systems/equipment packages, interfaces, and supporting deliverables, from design through PQ completion, where applicable.
• Own the complete end to end C&Q scope for Dirty Utilities including but not limited to: chilled water, heating hot water, HVAC, clean room construction, instrument air systems, fire alarm systems, wastewater, potable water, gas, electrical, etc.
• Define and maintain the assigned utility-system boundaries, system list, C&Q execution strategy, deliverables, resource plan, priorities, and integrated schedule.
• Represent C&Q during design reviews and ensure commissioning, qualification, operability, maintainability, automation, data integrity, and turnover requirements are incorporated into the design.
• Ensure C&Q requirements are translated into user requirements, system classifications, system-impact assessments, criticality and risk assessments, design reviews, traceability matrices, vendor documentation requirements, and verification plans.
• Apply ASTM E2500 and science- and risk-based verification principles to determine the appropriate balance of supplier testing, FAT, SAT, commissioning, qualification, and PQ activities.
• Lead C&Q input to equipment procurement and vendor management, including review of specifications, bids, document registers, FAT strategies, test protocols, punch items, release criteria, and open-item transfer to site.
• Own readiness and execution for FAT, SAT, commissioning, installation verification, operational qualification, utility-support testing, and PQ activities within the assigned utility-system scope.
• Partner with automation and utility engineering leads to integrate controls, interfaces, recipes, alarms, interlocks, data historian requirements, and computerized-system dependencies into the C&Q plan.
• Direct preparation, review, approval, execution, and close-out of C&Q deliverables, including DQs, risk assessments, traceability matrices, FAT/SAT protocols, commissioning test records, IV/OV protocols, test scripts, final summary reports.
• Coordinate system and area handoffs across construction completion, mechanical completion, energization, automation readiness, commissioning, qualification, operations acceptance, and final turnover.
• Lead execution readiness reviews and go/no-go decisions, confirming approved protocols, trained resources, safe work conditions, calibrated instruments, completed prerequisites, available utilities, automation readiness, and approved supporting documentation.
• Manage deviations, discrepancies, punch items, change controls, technical issues, and quality events; ensure risk is understood, ownership is clear, and closure evidence supports release and continued execution.
• Align C&Q activities and forecast dates with the integrated Primavera P6 schedule; identify constraints early, quantify impacts, escalate decisions, and lead recovery planning when milestones are threatened.
• Lead the utility-system C&Q team, including workload planning, daily priorities, resource forecasting, technical direction, coaching, quality review, and performance against schedule.
• Provide clear status reporting covering scope, schedule, readiness, execution progress, deviations, punch items, risks, decisions, and forecast completion dates.
• Ensure executed records are complete, traceable, data-integrity compliant, and inspection-ready, with final documentation reconciled and handed over in the approved electronic system.

Qualifications:

• 10+ years of C&Q experience, including greenfield project for pharmaceutical or biopharmaceutical manufacturing facilities.
• Strong practical knowledge of ASTM E2500 and leveraged verification, including the relationship between requirements, risk assessments, design verification, vendor testing, commissioning, qualification, and traceability.
• Experience managing teams for a unit operation from basis of design and requirements definition through system turnover and final handover.
• Experience coordinating with design, engineering, vendors, construction, automation, quality, C&Q, operations, maintenance, project controls, and system owners.
• Strong understanding of good documentation practices, data integrity, controlled templates, review and approval workflows, traceability, and inspection-ready records.
• Experience in managing greenfield projects as a Project Lead or CQ PM.

Additional Preferred Experience:

• Direct, high level experience using Kneat System for document generation and execution.
• Some knowledge of Primavera P6 for integrated schedule management.
• Experience supporting regulatory inspections, internal audits, or project quality reviews.

Benefits:

Benefits of full-time employment with ValSource will include:

• Paid Time Off (PTO) and Holidays
• Medical / Dental / Vision Insurance - premiums 100% paid by ValSource for Employee to Family level coverage
• Basic Life / Short- and Long-Term Disability / Voluntary Life / AD&D Insurance coverages
• ValSource 401(k) Plan
• ValSource Employee Stock Ownership Plan (ESOP)
• Paid Maternity / Paternity
• Medical Leave Pay
• Tuition Reimbursement / Continuing Education
• Annual Performance Bonus Compensation

Other information

Due to the full-time nature of these opportunities with ValSource, employment agencies or independent contractors need not respond. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

About ValSource:

ValSource is one of the largest independent Validation Services Company in North America with over 350 Engineering, Commissioning, Qualification and Validation employees. ValSource returns validation to a scientific event which helps companies design, perform and better control manufacturing processes throughout all stages of the operations life cycle. Full-time employees are offered a competitive compensation package that also includes full benefits (medical, dental, vision, short- and long-term disability), 401k, paid time off (holidays and vacation), continuous training and development, Employee Stock Ownership Plan, discretionary bonus, etc.

Equal Employment Opportunity

ValSource provides equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, genetic information, military, and veteran status.