Senior CQV Project Manager

Senior CQV Project Manager

Position located in Indianapolis, IN (full‑time onsite).

IPS-Integrated Project Services (IPS) is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. This role supports the Midwest Region, delivering cGMP compliance‑based services—commissioning, qualification, validation, and consulting—across pharmaceutical, biotech, and medical device projects.

• Lead multiple concurrent commissioning and compliance projects for IPS clients.
• Act as the primary IPS point of contact for client project delivery: conduct meetings, communicate status and issues, and coordinate activities with the IPS Project Lead.
• Prepare and manage project schedules, deliverable tracking reports, scope adjustment notices, and budget performance.
• Develop and manage C/Q/V documentation such as Master Plans, Commissioning Forms, Protocols and Summary Reports, SOPs, Impact Assessments, URS/FRS/DDS specifications, and FATS/SATs.
• Guide and mentor commissioning and validation specialists and project leaders.
• Assist in proposal development, including scope definition, bid meetings, cost budgeting, and presentations.
• Execute and supervise field and site activities: attend FATs/SATs, perform vendor start‑up and testing, walk‑downs, and system verification.
• Compile data packages and prepare completion reports (ETOPs, protocol data packages, etc.).
• Investigate and resolve deviations, issues, and non‑conformances during field execution.
• Audit project deliverables, review team work, and ensure compliance with IPS and regulatory standards.
• Represent IPS in developing new business opportunities and supporting repeat business.
• Execute C/Q/V of equipment and systems, including CSV and automation, for pharmaceutical, biotech, and medical device industries.
• Operate independently and lead teams in project delivery.
• Apply IPS Best Practices and SOPs throughout project execution.
• Demonstrate recognized expertise in areas such as Sterile, OSD, Bio Tech, Medical Device, or specific equipment/systems.

• Bachelor’s degree in engineering, project delivery, or a related discipline (or equivalent technical degree).
• 10+ years of experience in pharmaceutical, biotech, medical device design, construction, commissioning, validation, or QA.
• Experience with a risk‑based approach to commissioning and qualification.
• Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.).

• Experience writing and executing PFC, FC, IQ, OQ, and PQ forms/protocols for GMP utilities, equipment, systems, and software.
• PMP certification or Professional Engineer (PE) license.
• Experience in cleaning, process, computer systems, methods, and other validation activities.
• General exposure to GMP/validation disciplines with knowledge of U.S. and EU cGMP regulations.

• Up to 100% travel to client sites as required.
• Extended residencies at client locations may be necessary.
• Overnight travel and staying in the city of the client’s location possible.
• Travel will follow the IPS Travel Policy or client‑specific travel plans.
• Appropriate safety rules must be adhered to at client sites.
• IPS will not sponsor employment visas for this position.

All interviews are conducted in person or virtually (video required).

$138,400 – $184,550 (dependent on experience, skill set, and education).

IPS, a Berkshire Hathaway company, specializes in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for complex facilities. IPS blends design and delivery expertise, client‑side experience, and supplier‑side insight to accelerate time to market and deliver high‑quality solutions.

All qualified applicants will receive consideration for employment at IPS without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic predisposition or carrier status, veteran, marital, or citizenship status, or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer.