Project Manager in Boulder

Introduction

Visium Resources has been tasked with identifying qualified candidates for a full‑time Senior CQV Project Manager position located in Boulder, CO. The employer will consider candidates outside the commuting distance and provide monthly expenses for suitable applicants.

The Senior CQV Project Manager will lead commissioning, qualification, and validation activities for pharmaceutical manufacturing capital projects and operational initiatives. This role oversees 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.

• Experience leading major expansion C&Q projects from strategy and planning through full documentation preparation and execution.
• Writing CQV strategies and plans.
• Developing and managing CQV schedules.
• Experience with C&Q of process equipment.
• Knowledge of integrated CQV (ASTM E2500 and ISPE C&Q baseline guide).
• Experience with digital validation (e.g., Kneat or other software) is an asset but not required.
• Capital improvements experience is an asset but not required.

• 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.

• 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:
  • Clean rooms
  • Process equipment
  • Utilities
  • Automation systems
  • Manufacturing processes
• Experience authoring and reviewing validation lifecycle documentation.
• Demonstrated success leading cross‑functional teams and managing multiple project work streams simultaneously.
• Experience supporting FDA audits and regulatory inspections.
• Background in biologics, sterile fill‑finish, vaccine, API, or aseptic manufacturing environments is strongly preferred.

• Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related technical discipline.
• Strong understanding of:
  • cGMP regulations
  • FDA validation requirements
  • ISPE Baseline Guides (including 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.

• Digital Validation software experience (e.g., Kneat or equivalent).
• PMP certification.
• Experience with DeltaV, MES, SCADA, or other pharmaceutical automation platforms.
• Familiarity with Kneat, Track Wise, Veeva, or electronic validation systems.
• Previous consulting or EPCM experience is an advantage.

Visium Resources is an equal opportunity employer and values diversity. All employment is decided based on qualifications, merit, and business need.