Startup Manager

System One; Houston (TX); On-site; USD 90,000 - 140,000; Part time

Job summary

System One is seeking a Deputy Commissioning Manager to oversee commissioning, qualification and validation for a pharmaceutical manufacturing facility in Houston, TX. This contract role requires extensive CQV experience and strong leadership across process, mechanical, electrical, instrumentation, utilities, and automation disciplines.

The incumbent will coordinate daily commissioning activities, drive schedules, and ensure regulatory alignment with FDA cGMP, EU GMP, ISPE, and GAMP 5.

Qualifications

• Bachelor's degree in Engineering, Construction Management, or related technical discipline; PE preferred.
• 10+ years of industrial commissioning, startup, CQV, or facility operations experience.
• Minimum 5 years of pharmaceutical, biotechnology, life sciences, or regulated manufacturing experience.
• Demonstrated experience supporting large capital projects ($200M+ preferred).
• Experience with commissioning through qualification and operational readiness phases.
• Excellent communication and stakeholder engagement skills for coordination with engineering, operations, and client teams.
• Experience in Commissioning or a technical consulting field such as facility design, engineering, construction management or related area.
• Strong understanding of cGMP, FDA/EU GMP, ISPE Baseline Guides, GAMP 5, CQV methodologies, MV processes.

Responsibilities

• Assist the Commissioning Manager in developing strategies, procedures, and project execution plans.
• Coordinate day-to-day commissioning activities across process, mechanical, electrical, instrumentation and controls.
• Lead commissioning teams to achieve milestones safely and efficiently.
• Develop and manage commissioning schedules, resource plans, and turnover priorities.
• Facilitate commissioning meetings and provide status updates to leadership.
• Ensure alignment between Commissioning and CQV activities throughout the project lifecycle.
• Coordinate with Validation teams to ensure documentation meets regulatory expectations.
• Review drawings, control schematics, and project specs for turnover readiness.
• Develop turnover strategies between Construction, Commissioning, CQV and Operations.

Skills

Industrial commissioning experience

Pharmaceutical/CQV experience

Strong communication

Education

Bachelor's Degree in Engineering, Construction Management, or related technical discipline

Professional Engineering (PE) registration preferred

Job description

Job Title: Deputy Commissioning Manager CQV

Location: Houston, TX

Type: Contract

Compensation: DOE

Work Model: Onsite – onsite

Hours: 40.0

Security Clearance: Not specified

System One is seeking a high-caliber Deputy Commissioning Manager to ensure stands for commissioning, qualification and validation for a pharmaceutical manufacturing facility.

• Deputy Commissioning Manager Responsibilities Assist the Commissioning Manager in the development and implementation of commissioning strategies, procedures, and project execution plans.
• Coordinate day-to-day commissioning activities across process, mechanical, electrical, instrumentation, controls, utilities, and automation systems.
• Lead commissioning teams and discipline engineers to achieve project milestones safely and efficiently.
• Support development and management of commissioning schedules, resource plans, and system turnover priorities.
• Facilitate commissioning meetings and provide regular status updates to project leadership.
• Ensure alignment between Commissioning and CQV activities throughout the project lifecycle.
• Support development of turnover strategies between Construction, Commissioning, CQV, and Operations.
• Verify commissioning documentation supports Qualification requirements and minimizes duplicate testing.
• Participate in CQV planning sessions and readiness reviews.
• Coordinate with Validation teams to ensure documentation packages meet regulatory expectations.
• Ensure all commissioning activities comply with:
  • FDA cGMP requirements
  • EU GMP requirements
  • ISPE Baseline Guides
  • GAMP 5 principles
  • Good Documentation Practices (GDP)
  • Support data integrity and controlled documentation processes.
  • Promote a quality-by-design and right-first-time approach throughout project execution.
• Support development and management of:
  • System Boundary Drawings
  • System Turnover Packages (STPs)
  • Mechanical Completion Packages (MCPs)
  • Commissioning Turnover Packages
    • Coordinate successful transition of systems from Construction to Commissioning and ultimately to CQV and Operations.
    • Develop and maintain commissioning schedules, checklists, and test procedures.
    • Develop and implement commissioning plans, test scripts, Energization Plans and acceptance criteria in alignment with project requirements.
    • Review and interpret drawings, P&A diagrams, control schematics, and project specifications.
    • Coordinate with engineering, construction, QA/QC, and operations teams to ensure a seamless transition from construction to operations.
    • Coordinate with Commissioning Team, Design Engineers, Construction teams, vendors, and owner representatives to resolve technical issues.

Deputy Commissioning Manager Requirements

• Bachelor's Degree in Engineering, Construction Management, or related technical discipline. Professional Engineering (PE) registration preferred.
• 10+ years of industrial commissioning, startup, CQV, or facility operations experience.
• Minimum 5 years of pharmaceutical, biotechnology, life sciences, or regulated manufacturing experience.
• Demonstrated experience supporting large capital projects ($200M+ preferred).
• Experience with commissioning through qualification and operational readiness phases.
• Excellent communication and stakeholder engagement skills for coordination with engineering, operations, and client teams.
• Experience in Commissioning or a technical consulting field such as facility design, engineering, construction management or related area.
• Identifies owners goals, needs, and expectations for building operation and function; identifies the Commissioning responsibilities.
• Demonstrated background working with multidisciplinary teams.
• Strong understanding of:
  • cGMP Regulation
  • FDA and EU GMP Requirement
  • ISPE Baseline Guides
  • GAMP 5
  • CQV Methodologies
  • Mechanical Completion Processes
  • Turnover Management
  • Process Utilities
  • HVAC Systems
  • Building Management Systems (BMS)
  • Environmental Monitoring Systems (EMS)

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #275-Eng Kansas City