CQV, Project Leader

IPS - Integrated Project Services, LLC; Indianapolis (IN); On-site; USD 80,000 - 120,000; Full time

Job summary

Join a forward-thinking company dedicated to delivering world-class designs for the pharmaceutical industry. As a CQV Project Leader, you will leverage your expertise in GMP compliance to tackle complex challenges in biotech and pharmaceutical manufacturing. This role offers the opportunity to lead projects, mentor validation specialists, and ensure the highest standards of quality and compliance. With a commitment to innovation and excellence, this established industry player is poised to elevate your career while making a meaningful impact on life-changing products. Be part of a dynamic team that values collaboration and professional growth.

Qualifications

• 5+ years of experience in Pharmaceutical, Biotech, Medical Device Design, or QA.
• Experience with writing and executing GMP protocols for Utilities and Equipment.

Responsibilities

• Assist in the delivery of compliance projects and provide project status feedback.
• Prepare and manage C/Q/V documents and support proposal development.

Skills

GMP Compliance

Project Management

Validation Protocols (IQ, OQ, PQ)

Microsoft Office

Risk-Based Approach

Education

Bachelor of Science in Engineering

Job description

Job Description

At IPS, you will apply your knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to pharmaceutical, biotech, and animal health research and manufacturing facilities. We are looking for a CQV Project Leader to join our team at our office located in ____________.

In this role, you will perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as outlined in project agreements with IPS clients. You will interface directly with clients during project delivery and may also manage standalone commissioning services for non-FDA regulated clients.

Position Responsibilities

1. Assist an assigned Project Manager or be solely responsible for the successful delivery of compliance projects.
2. Provide timely feedback and reports regarding project status and issues.
3. Develop project schedules, tracking reports, and scope adjustment notices.
4. Support, train, and guide validation specialists/engineers in delivering C/Q/V services.
5. Prepare and manage C/Q/V documents following established standards, including Master Plans, Protocols, Reports, SOPs, Impact Assessments, Specifications, and FATs/SATs.
6. Manage field/site activities such as witnessing FATs and SATs, executing commissioning forms, verifying system drawings, and assisting in deviation investigations.
7. Coordinate start-up and vendor testing with the Project Delivery department or Construction Management.
8. Support proposal development including scope definition, bid meetings, and budget estimates.
9. Perform C/Q/V of equipment and systems supporting pharmaceutical, biotech, and medical device industries.

Join our caring, agile team that delivers world-class designs for pharmaceutical clients and elevates your career!

Qualifications & Requirements

1. Bachelor of Science in Engineering for Engineers; related field for Validation Specialists.
2. 5+ years of experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
3. Experience in writing and executing PFC, FC, IQ, OQ, PQ protocols for GMP Utilities, Equipment, Systems, and Software.
4. Experience with cleaning, processes, computer systems, and validation activities is beneficial.
5. Understanding of GMP/Validation disciplines and pharmaceutical regulations.
6. Experience with a risk-based approach to commissioning and qualification is beneficial.
7. Proficiency in Microsoft Office applications.
8. Knowledge of project management principles.

About Us

IPS, a Berkshire Hathaway company, is a global leader in biotech and pharmaceutical solutions, with over 3,500 professionals across 45 offices worldwide. We provide consultancy, engineering, project controls, construction management, and compliance services to help clients develop life-impacting products. Visit www.ipsdb.com for more information.

IPS is an equal opportunity employer and values diversity in the workplace.