Senior Commissioning & Qualification Manager

Adryan; Town of Texas (WI); On-site; USD 180,000 - 260,000; Full time

Job summary

Adryan seeks a seasoned Senior C&Q Manager to own the integrated commissioning and qualification program for a high-scale U.S. manufacturing campus. You will lead from design through handover, shaping the strategy and directing a cross-functional delivery team in a regulated environment, with on-site oversight.

The role requires 15+ years in CQV/validation, strong leadership across multi-company teams, and deep knowledge of facilities, utilities and automation. Regular on-site work is essential.

Qualifications

• 15+ years of CQV, validation, engineering or capital-project experience in FDA-regulated manufacturing.
• Led greenfield or major brownfield programs with total capital value of $300M+.
• Proven ability to lead large, multi-company teams across design, construction and start-up.
• Deep hands-on knowledge of facilities, HVAC/cleanrooms, utilities, process equipment, automation.
• Strong command of system-based turnover, risk-based qualification, schedule integration, budget control.
• Executive-level communication and stakeholder-management skills, with field problem-solving.
• Bachelor’s degree in engineering, life sciences or related discipline, or equivalent.
• Fluent English; eligible to work in the United States; regular on-site presence.

Responsibilities

• Own the integrated CQV program from design development through construction completion, start-up, qualification and handover to operations.
• Create and govern the CQV Master Plan, system boundaries, turnover strategy and execution plans.
• Recruit, onboard and lead a multidisciplinary team of leads, engineers, contractors and vendors.
• Shape the CQV delivery model to support modular design and future expansion.
• Manage CQV budget, schedule, risk register and executive reporting; protect critical path to start-up.
• Establish a risk-based, science- and engineering-led model aligned with ASTM E2500, FDA expectations and GMP requirements.
• Drive design reviews, FAT/SAT strategy, commissioning, IQ/OQ and performance verification.
• Ensure turnover packages are complete, traceable and inspection-ready; resolve deviations without losing momentum.
• Integrate CQV with construction, automation/CSV, validation, tech transfer and operations.

Skills

CQV leadership

Stakeholder management

Project management

Regulatory awareness

Executive communication

Team leadership

English fluency

Education

Bachelor’s degree in engineering or life sciences

Tools

Kneat

ValGenesis

Job description

Adryan is seeking a seasoned CQV leader to shape and deliver the commissioning and qualification program for a highly ambitious, modular and expandable U.S. manufacturing campus. The assignment calls for a leader who has already delivered at comparable scale – someone equally credible in the boardroom, the design office and the field.

The role

As Senior C&Q Manager, you will own the integrated commissioning and qualification program from design development through construction completion, start-up, qualification, regulatory readiness and handover to operations. You will translate the project and quality strategy into an executable system-based plan, build the delivery organization and provide clear leadership across client, EPCM, construction, vendor, automation, quality and operations teams.

Responsibilities

• Develop, maintain and govern the CQV Master Plan, system boundaries, system impact assessments, turnover strategy, test matrices and phase-specific execution plans.
• Create the CQV organization and resource plan; recruit, onboard and lead a multidisciplinary team of leads and engineers, including contractors and specialist vendors.
• Shape the CQV delivery model early in the project, ensuring that modular design, future expansion, procurement packages and construction sequencing support an efficient, right-first-time start-up.
• Own the CQV budget, integrated schedule, progress measurement, forecasting, risk register and executive reporting; protect the critical path to start-up and licensure.
• Establish a risk-based, science- and engineering-led delivery model aligned with ASTM E2500, ISPE guidance, FDA expectations, 21 CFR Parts 11/210/211 and applicable global GMP requirements.
• Drive design reviews, constructability and operability input, FAT/SAT strategy, mechanical completion, walkdowns, punch-list closure, commissioning, IQ/OQ and performance verification.
• Ensure vendor documentation and turnover packages are complete, traceable and inspection-ready; resolve deviations, changes and quality issues without losing delivery momentum.
• Integrate CQV with construction, automation/CSV, process validation, tech transfer, operational readiness, maintenance, training and site acceptance.
• Act as the senior CQV contact for project governance, Quality and regulatory inspections, and lead the final handover to system owners and operations.

Your profile

• 15+ years of CQV, validation, engineering or capital-project experience in FDA-regulated pharmaceutical or biotechnology manufacturing, including substantial time in senior leadership roles.
• Demonstrated ownership of CQV on a greenfield or major brownfield program with total capital value of at least $300 million.
• Proven ability to build and lead large, multi-company teams and manage a portfolio of complex GMP systems across overlapping design, construction and start-up phases.
• Deep hands‑on knowledge of facilities, HVAC/cleanrooms, clean and black utilities, process equipment, automation and computerized-system interfaces.
• Strong command of system-based turnover, risk-based qualification, schedule integration, budget control, change/deviation management and inspection readiness.
• Executive-level communication and stakeholder‑management skills, combined with the practical judgment to resolve issues in the field.
• Bachelor’s degree in engineering, life sciences or a related technical discipline, or equivalent depth of relevant industry experience.
• Fluent English and eligibility to work in the United States. Regular on‑site presence is essential.

Preferred Experience

• Greenfield biologics, sterile manufacturing, cell therapy, advanced therapies or other complex multi-product manufacturing experience.
• Experience setting strategy during concept/basic design and carrying accountability through detailed design, construction and start‑up.
• Working knowledge of digital CQV platforms such as Kneat or ValGenesis and integrated project controls tools.
• Experience with modular construction, large EPCM organizations and major U.S. permitting/construction interfaces.
• PMP, CPIP or comparable project/industry certifications.

Adryan is an equal opportunity employer. We welcome qualified applicants from all backgrounds.