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Biotech Project Management Jobs in Colorado (NOW HIRING)

Medpace, Inc.

Oncology Project Manager

Denver, CO · On-site +1

$80K - $120K/yr

Utilize study management tools to track: site start-up activities, site performance issues ... We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and ...

Medpace, Inc.

Oncology Project Manager

Denver, CO · On-site

$80K - $120K/yr

Utilize study management tools to track: site start-up activities, site performance issues ... We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and ...

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Biotech Project Management information

What are the key skills and qualifications needed to thrive in the Biotech Project Management position, and why are they important?

To thrive in Biotech Project Management, you need a strong background in life sciences, experience in project planning and execution, and ideally a relevant degree (such as biology, biotechnology, or project management certification). Familiarity with project management software (like MS Project or Asana), regulatory compliance systems, and possibly certifications like PMP is often expected. Exceptional communication, leadership, problem-solving, and time management skills will help you stand out in this role. These competencies ensure projects remain on schedule, compliant, and collaborative in the fast-paced, highly regulated biotech industry.

What are the most common challenges faced by professionals in Biotech Project Management roles?

Biotech Project Management professionals often juggle cross-disciplinary teams, tight timelines, and complex regulatory requirements, which can make prioritizing tasks a challenge. Navigating scientific uncertainties and adapting to project scope changes are daily realities given the fast pace of biotech innovation. Having strong organizational and people skills helps to manage competing priorities while keeping all stakeholders aligned. By mastering these challenges, professionals can significantly contribute to the timely advancement of vital scientific initiatives.

What is a Biotech Project Management job?

A Biotech Project Management job involves overseeing and coordinating research, development, and commercialization projects in the biotechnology industry. Project managers in this field ensure that scientific, regulatory, and business objectives are met on time and within budget. They work closely with cross-functional teams, including scientists, regulatory experts, and business stakeholders, to drive project success. Strong organizational, problem-solving, and communication skills are essential for managing risks and ensuring compliance with industry regulations.

What are the most commonly searched types of Biotech Project Management jobs in Colorado? The most popular types of Biotech Project Management jobs in Colorado are:
What are popular job titles related to Biotech Project Management jobs in Colorado? For Biotech Project Management jobs in Colorado, the most frequently searched job titles are:
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What cities in Colorado are hiring for Biotech Project Management jobs? Cities in Colorado with the most Biotech Project Management job openings:
Biotech Project Management jobs near you
Project Manager - Senior CQV Pharmaceutical

Project Manager - Senior CQV Pharmaceutical

Visium Resources, Inc.

Boulder, CO • On-site

Full-time

This job post has expired today. Applications are no longer accepted.

Job description

Introduction
Visium Resources has been asked to identify qualified candidates for a full time position as a Senior CQV Project Manager located in Boulder, CO. 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.

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Visium Resources is an award-winning employment firm with a mission to match talented individuals with highly successful organizations. At Visium, our company's success is based on your success. When you work with us, you are never 'just a number'. You are our most important asset. Here, you will know us by name through our regular visits to client sites and even occasional luncheons. We will always be there when you need assistance and will always go the extra mile to ensure that you are as successful as possible. Whether you're looking for contract, contract-to-hire or permanent opportunities, we firmly believe there is no employment agency that will work harder for you than Visium.
Visium Resources is an equal opportunity employer and values diversity. All employment is decided based on qualifications, merit and business need.