Commissioning Manager/ Validation Manager/CQV Manager

Job Description

Job Description

Role: Commissioning Manager/ Deputy Commissioning Manager/CQV Manager/Validation Manager/Commissioning Superintendent/Commissioning Supervisor

Duration: 12 Months

Location: Chandler, AZ 85224 / Houston, TX 77056

Details:

· The 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.

· Collaborate: Actively seeks out others’ opinions and input and is open-minded to their views. Challenges others appropriately and is also open to being challenged on their own views.

· Communicate: Is effective at adapting their communication style appropriately to their audience, providing context and using the right tone and level of information.

· Customer Focus: Prioritizes the customer needs and puts these at the forefront of all interactions. Ensure that others within their team maintain this same approach.

· Deliver: Demonstrates making well thought out, timely decisions and prioritization that leads to successful outcomes. Includes the right people at the right time.

· Problem Solve: Accurately assesses a situation to find the best solution or way of working in order to resolve the issues. It is focused on creating a long-term fix rather than a short-term solution.

· Role Model: Contributes to the Client culture by inspiring and motivating others through their positive approach and attitude. Comes to work determined to do a good job, for themselves and for their team.

· "This position is designated as part-time telework per our global telework policy and will require at least three days of in-person attendance per week at the assigned office or project. Weekly in-person schedules will be determined by the individual and their supervisor, in consultation with functional or project leadership"

Major 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.

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.

· cGMP Compliance

· 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.

· System Turnover & Mechanical Completion

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&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.

Education and Experience Requirements:

· Bachelor’s degree in engineering construction management or related technical discipline. Professional Engineering (PE) registration preferred.

o 10+ years of industrial commissioning, startup, CQV, or facility operations experience.

o Minimum 5 years of pharmaceutical, biotechnology, life sciences, or regulated manufacturing experience.

o Demonstrated experience supporting large capital projects ($200M+ preferred).

o 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.

o Experience in Commissioning or a technical consulting field such as facility design, engineering, construction management or related area.

o Identifies owner’s goals, needs, and expectations for building operation and function; identifies the Commissioning responsibilities.

o 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)

The Deputy Commissioning Manager will be measured by:

• Safe execution of commissioning activities.

• On-time system turnover and startup milestones.

• Successful CQV integration and regulatory compliance.

• Reduction of rework and duplicate testing.

• Quality and completeness of turnover documentation.

• Effective management of project risks and interfaces.

• Achievement of operational readiness and successful facility startup.

Software Galaxy Systems, LLC (SGS) is an award-winning Contingent Workforce Services firm providing a broad range of integrated suite of services through a global delivery platform. SGS brings innovative talent management strategies to empower its clients to stay focused on growth of their core competencies. SGS has developed a comprehensive process-oriented methodology to manage high-volume contingent labor, payroll services and SOW’s for today’s competitive landscape.

SGS is proud of the partnerships it has built with its clients, MSP’s, and employees which has allowed it to deliver unparalleled service to its wide-ranging customer base. SGS is a certified minority owned enterprise that provides innovative yet practical solutions, from concept through execution. We combine technology with strategy and aim to deliver results today that endure tomorrow. SGS’ client centric approach delivers unparalleled value with vastly responsive, streamlined and highly process oriented workforce solutions.

SGS has been awarded and acknowledged by leading MSP’s (i.e., KellyOCG, TAPFIN, Guidant Global, etc.) for its exemplary performance in the contingent workforce space.

Company Description

Software Galaxy Systems, LLC (SGS) is an award-winning Contingent Workforce Services firm providing a broad range of integrated suite of services through a global delivery platform. SGS brings innovative talent management strategies to empower its clients to stay focused on growth of their core competencies. SGS has developed a comprehensive process-oriented methodology to manage high-volume contingent labor, payroll services and SOW’s for today’s competitive landscape.\r\n\r\nSGS is proud of the partnerships it has built with its clients, MSP’s, and employees which has allowed it to deliver unparalleled service to its wide-ranging customer base. SGS is a certified minority owned enterprise that provides innovative yet practical solutions, from concept through execution. We combine technology with strategy and aim to deliver results today that endure tomorrow. SGS’ client centric approach delivers unparalleled value with vastly responsive, streamlined and highly process oriented workforce solutions.\r\n\r\nSGS has been awarded and acknowledged by leading MSP’s (i.e., KellyOCG, TAPFIN, Guidant Global, etc.) for its exemplary performance in the contingent workforce space.