CQV Lead

4 days ago

Indianapolis, Indiana, United States ENG Bauen Full time $120,000 - $250,000 per year

CQV Lead | Indiana, USA

Drive Commissioning, Qualification & Validation Across Major Pharmaceutical Projects

We are seeking an experienced CQV Lead to oversee commissioning, qualification, and validation (CQV) activities across large-scale pharmaceutical manufacturing projects in the United States. This position plays a key leadership role in ensuring that new facilities, systems, and processes are delivered safely, efficiently, and fully compliant with GMP and regulatory standards.

As part of our client's long-term investment in expanding U.S. manufacturing capacity, this role will take ownership of CQV strategy and execution on projects valued at $250M+, ensuring seamless transition from construction through to operational readiness and product release. You will be instrumental in building next-generation pharmaceutical facilities that deliver innovation, resilience, and operational excellence.

The Opportunity:

  • Develop and lead CQV execution strategies across capital projects, ensuring compliance with corporate and regulatory standards.
  • Oversee commissioning and validation of utilities, equipment, process systems, and cleanroom environments.
  • Define project CQV plans, resource requirements, and schedules aligned with construction and automation milestones.
  • Collaborate closely with engineering, construction, automation, and quality teams to ensure coordinated project delivery.
  • Lead FATs, SATs, IQ/OQ/PQ activities, and final turnover documentation to operations.
  • Manage vendor qualification, validation documentation, and system handover readiness.
  • Ensure all CQV activities adhere to current GMP, regulatory expectations, and site quality systems.
  • Drive continuous improvement and efficiency in validation execution methodologies.

Ideal Profile for the Opportunity:

  • Bachelor's or Master's degree in Engineering, Life Sciences, or related technical discipline.
  • 10+ years' experience in CQV leadership roles within pharmaceutical or biotech manufacturing environments.
  • Proven track record leading CQV activities on large-scale CAPEX or greenfield projects ($100M–$500M+).
  • Deep knowledge of cGMP, FDA, EMA, and ISPE baseline guides.
  • Strong experience managing multi-disciplinary teams and coordinating with EPC/EPCM partners.
  • Excellent communication, stakeholder management, and leadership skills.

Connect With Us:

If you are looking to take a leading role in shaping CQV strategy on major life sciences projects, we'd like to hear from you. Let's explore how your expertise can support the delivery of next-generation pharmaceutical facilities.

Keywords:
CQV Lead, Commissioning, Qualification, Validation, Life Sciences, Pharmaceuticals, GMP, FDA, CAPEX Projects, Greenfield Projects, Engineering, Project Delivery, Operational Readiness, EPCM, DeltaV, Indiana

  • Associate Director

    4 hours ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time $118,500 - $173,800

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Project Engineer

    2 weeks ago

    Indianapolis, Indiana, United States i-Pharm GxP Full time

    Job Title:Piping Project Engineer / Project ManagerLocation:Indiana (onsite)Industry:Pharmaceutical / Biotech / Life SciencesType:ContractOverview:Our client, a leading pharmaceutical manufacturer in Indiana, is seeking an experiencedPiping Project Engineer / Project Managerto support the design, coordination, and execution ofprocess and hygienic piping...

  • Filling CQV Engineer Jr.

    3 days ago

    Indianapolis, United States Zachary Piper Solutions Full time

    The Filling CQV Engineer Jr. will join a leading global pharmaceutical company that is rapidly expanding its international presence, with plans to double in both size and production in the coming years. This role supports a Manufacturing Facility in Indianapolis, Indiana, and focuses on commissioning, qualification, and validation (CQV) of aseptic filling...

  • Associate Director

    2 weeks ago

    Indianapolis, United States Eli Lilly and Company Full time

    Associate Director - Project Engineering and CQV page is loaded## Associate Director - Project Engineering and CQVlocations: US, Indianapolis INtime type: Full timeposted on: Posted 2 Days Agojob requisition id: R-92793At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader...

  • Associate Director

    2 weeks ago

    Indianapolis, United States Eli Lilly and Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Senior CQV Project Manager

    2 weeks ago

    Indianapolis, United States IPS-Integrated Project Services, LLC Full time

    At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated Senior CQV Project Manager to join our talented team supporting the Midwest Region. Project Site: Indianapolis, IN (full-time onsite) In this role, you will perform cGMP...

  • Commissioning Qualification Validation Engineer

    2 weeks ago

    Indianapolis, United States Piper Companies Full time

     DescriptionPiper Companies is currently looking for an experienced Commissioning Qualification Validation Engineer (CQV) in Indianapolis, Indiana (IN).Responsibilities for the Commissioning Qualification Validation Engineer (CQV)include:·Commissioning: Lead commissioning activities for new laboratory equipment, systems, and facilities, ensuring they...

  • Commissioning Qualification Validation Engineer

    3 days ago

    Indianapolis, IN, United States Piper Companies Full time

    Description Piper Companies is currently looking for an experienced Commissioning Qualification Validation Engineer (CQV) in Indianapolis, Indiana (IN).Responsibilities for the Commissioning Qualification Validation Engineer (CQV) include: • Commissioning: Lead commissioning activities for new laboratory equipment, systems, and facilities, ensuring they...

  • Senior CQV Project Manager

    1 week ago

    Indianapolis, United States IPS-Integrated Project Services, LLC Full time

    Job Description At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated Senior CQV Project Manager to join our talented team supporting the Midwest Region. Project Site: Indianapolis, IN (full-time onsite) In this role, you will...

  • Senior CQV Project Manager

    1 week ago

    Indianapolis, IN, United States IPS-Integrated Project Services, LLC Full time

    Job Description At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated Senior CQV Project Manager to join our talented team supporting the Midwest Region. Project Site: Indianapolis, IN (full-time onsite) In this role, you will...

  • Senior CQV Project Manager

    6 days ago

    Indianapolis, IN, United States IPS-Integrated Project Services, LLC Full time

    Job Description At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated Senior CQV Project Manager to join our talented team supporting the Midwest Region. Project Site: Indianapolis, IN (full-time onsite) In this role, you will...

  • Senior CQV Project Manager

    3 days ago

    Indianapolis, IN, United States IPS-Integrated Project Services, LLC Full time

    Job Description At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated Senior CQV Project Manager to join our talented team supporting the Midwest Region. Project Site: Indianapolis, IN (full-time onsite) In this role, you will...