Project Manager - Senior CQV Pharmaceutical

Visium Resources has been asked to identify qualified candidates for a full time position as a Senior CQV Project Manager. Required to work onsite in Boulder, CO and employer will pay monthly expenses for commute. We are seeking an experienced Senior CQV Project Manager to lead commissioning, qualification, and validation activities for pharmaceutical manufacturing capital projects and operational initiatives. This individual will oversee cross-functional CQV execution for GMP-regulated facilities, utilities, equipment, automation systems, and manufacturing processes while ensuring compliance with FDA, cGMP, and global regulatory standards.

The ideal candidate will possess strong pharmaceutical project leadership experience within biotech, sterile manufacturing, fill-finish, API, or biologics environments and will serve as a key liaison between engineering, quality, validation, manufacturing, and external vendors. This role requires the ability to manage project schedules, budgets, risks, resources, and validation deliverables in support of facility expansions, new product introductions, and operational readiness initiatives.

Key Success Criteria

• Experience leading major expansion C&Q projects start to finish (brownfield or greenfield). From strategy / planning through to full doc prep & execution
• Writes CQV Strategies & Plans.
• CQV Schedule
• Should have experience with C&Q of process equipment.
• Has experienced with integrated CQV (ASTM E2500 and ISPE C&Q baseline guide)
• Has experience with digital validation (i.e. Kneat or other software) is a major asset but not required.
• Capital Improvements experience is a major asset but not required.

Key Responsibilities

• Lead all CQV project activities for pharmaceutical and biotech manufacturing projects.
• Develop and manage CQV strategies, project plans, schedules, budgets, and resource allocation.
• Coordinate commissioning and qualification activities for:
• Process equipment
• Clean utilities
• HVAC systems
• Automation and control systems
• Manufacturing and packaging lines
• Ensure compliance with FDA, cGMP, ISPE, GAMP, and corporate quality standards.
• Oversee execution of:
• FAT/SAT protocols
• IQ/OQ/PQ protocols
• Validation documentation
• Deviations and CAPAs
• Change controls
• Collaborate with Quality Assurance, Engineering, Manufacturing, Automation, and Regulatory teams to support project milestones and inspection readiness.
• Manage third-party CQV consultants, contractors, and vendors.
• Provide risk assessments and mitigation strategies to maintain project timelines and compliance objectives.
• Support startup, operational readiness, and technology transfer activities.
• Present project status updates and KPI reporting to senior leadership and stakeholders.

Qualified candidates would have the following:

• Minimum 8-12 years of experience in pharmaceutical, biotech, or life sciences industries.
• Minimum 5 years of direct CQV project management experience within GMP-regulated manufacturing environments.
• Proven experience managing large-scale capital projects, facility expansions, or greenfield startup projects.
• Strong experience with commissioning and qualification of:
• Cleanrooms
• Process equipment
• Utilities
• Automation systems
• Manufacturing processes
• Experience authoring and reviewing validation lifecycle documentation.
• Demonstrated success leading cross-functional teams and managing multiple project workstreams simultaneously.
• Experience supporting FDA audits and regulatory inspections.
• Background in biologics, sterile fill-finish, vaccine, API, or aseptic manufacturing environments strongly preferred.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related technical discipline.
• Strong understanding of:
• cGMP regulations
• FDA validation requirements
• ISPE Baseline Guides (inc. C&Q) and ASTM E2500 GUIDE
• GAMP 5 principles
• Proficiency with project management methodologies, scheduling tools, and reporting systems.
• Excellent communication, leadership, and stakeholder management skills.
• Ability to work effectively in fast-paced, highly regulated project environments.

Preferred Qualifications

• Digital Validation software experience (i.e. Kneat or equivalent)
• PMP certification preferred.
• Experience with DeltaV, MES, SCADA, or other pharmaceutical automation platforms.
• Familiarity with Kneat, TrackWise, Veeva, or electronic validation systems.
• Previous consulting or EPCM experience is a plus.