Project Manager, CQV

barrywehmiller; Indianapolis (IN); On-site; USD 110,000 - 170,000; Full time

Job summary

Barry-Wehmiller Design Group is seeking a Project Manager, CQV to join our team in the United States, supporting validation efforts for capital projects across life sciences sectors. You will collaborate with clients and internal teams to deliver compliant, high-quality validation solutions.

You will lead projects across commissioning, qualification, and validation, ensuring scope, cost, schedule, and risk management are effectively controlled while mentoring junior staff and advancing client

Qualifications

• Minimum of 7 years' experience in validation/quality service and project management in life sciences or FDA-regulated projects.
• Experience with project management, good documentation practices, cGMP, and FDA validation methods.

Responsibilities

• Interface with clients, lead teams of validation professionals, and provide subject matter expertise in validation of utility, facility, and process equipment.
• Help lead business development efforts in the region related to engaging with new life sciences clients.
• Develop project scope statements, estimates and proposals.
• Work on multiple projects simultaneously.
• Technical contributor in commissioning, qualification, and validation projects, developing sound validation approaches and leading execution when necessary.

Skills

Project management

Validation

Leadership

Communication

Documentation

Tools

GAMP methodologies

21 CFR Part 11

Job description

About Us:

BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, we combine deep domain expertise in the manufacturing environment with an approach that is built to serve the dynamic needs of our clients. Rooted in our distinct culture of Truly Human Leadership, we cultivate the leaders who will define tomorrow and partner with our clients in the food & beverage, life sciences, industrial, and advanced technology industries to build the future of manufacturing and technology.

Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world.

Job Description:

Project Manager, CQV

Who You'll Work With

You will join one of our 45 offices in the US, be part of a committed team of over 1800 professionals, and work in teams and directly with our clients doing work that is shaping the world around us. You will be welcomed into a rapidly growing business and team and empowered to make an impact. You will be valued, cared for, and challenged on your path to becoming a world-class professional consultant and surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment.

When you join Design Group as a Validation Project Manager, you are joining a team that will challenge you and position you for growth. In this role, you will work with a team of industry experts to help the world's leading companies solve their most difficult problems. You will join our Regulatory Compliance Practice and partner with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to our clients with consistency and accuracy.

What You'll Do

You’ll work individually and in teams to support capital projects and implement solutions for our clients. Together, you will help our clients make critical changes to improve their performance and realize their most important goals.

• Interface with clients, lead teams of validation professionals, and provide subject matter expertise in the validation of a variety of utility, facility, and process equipment.
• Help lead business development efforts in the region as it relates to engaging with new clients in the life sciences sector, and expanding our engagements with existing clients
• Develop project scope statements, estimates and proposals.
• Work on multiple projects simultaneously
• Technical individual contributor in commissioning, qualification, and validation projects. Able to work with clients and project teams on developing sound, compliant validation approaches to FUE qualification, generate protocols and lead execution efforts, when necessary.

What You'll Bring

• A passion for a career in the Life Science industry
• Minimum of 7 years' experience with increasing responsibility in validation/quality service and project management of life sciences, biotech or other FDA regulated projects.
• Experience with project management, good documentation practices, cGMP, & FDA validation methods and systems, ability to read engineering documents, set priorities, and work on multiple projects simultaneously.
• Strong understanding of EPCMV, Quality by Design and risk‑and science‑based approaches for compliance are desired.
• Experience with system and process risk assessments; including FMEA, HAZOP and Fault Tree Analysis desired.
• Experience with financial systems, project, and client administration
• Strong leadership, verbal communication, technical writing, project management tools and word processing skills.
• Diverse experience in leading project teams related to the commissioning and qualification of clean utilities, facility systems, process support systems, bioprocess manufacturing systems, packaging equipment, and process and cleaning validation is desirable.
• Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 compliance and latest industry expectations for data integrity.
• Project Management experience in managing scope, cost, schedule, quality and risk is required.
• Experience in mentorship and multi-discipline collaboration
• Displayed leadership in a consulting and service environment
• Willing and able to travel as necessary for project requirements to include but not be limited to: project installation and start-up activities, client meetings, company sponsored meetings, trainings, indus