Deputy Commissioning Manager CQV

Job Title: Deputy Commissioning Manager CQV

Location: Houston, Texas

Type of Role: Contract

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POSITION OVERVIEW:

The Deputy Commissioning Manager supports the Commissioning Manager in planning, coordinating, and executing all Commissioning, Qualification, and Validation (CQV) activities for a cGMP pharmaceutical manufacturing facility. The role ensures systems are safely commissioned, thoroughly documented, and transitioned to Qualification and Validation in compliance with regulatory requirements, project procedures, and client quality standards.

The Deputy Commissioning Manager serves as a key interface between Engineering, Construction, Operations, Quality Assurance, Validation, Equipment Vendors, and Project Management teams to ensure successful project delivery from Mechanical Completion through Operational Readiness.

RESPONSIBILITIES AND ESSENTIAL DUTIES:

• 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.
• CQV Integration
• 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.
• 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&ID 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.

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 & Management Of:

System Boundary Drawings

• System Turnover Packages (STPs)

• Mechanical Completion Packages (MCPs)

• Commissioning Turnover Packages

MINIMUM 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.

Required Knowledge and Skills:

• 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 areas.
• Identifies owner's goals, needs, and expectations for building operation and function; identifies the Commissioning responsibilities.
• Demonstrated background working with multidisciplinary teams.

Technical Knowledge Strong understanding of:

• cGMP Regulations
• FDA and EU GMP Requirements
• ISPE Baseline Guides
• GAMP 5
• CQV Methodologies
• Mechanical Completion Processes
• Turnover Management
• Process Utilities
• HVAC Systems
• Building Management Systems (BMS)
• Environmental Monitoring Systems (EMS)

Global Edge Consultants, LLC is an Equal Opportunity Employer. xhyhwjd The Global Ede Consultants, LLC does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.