Project Manager, CQV

About the role

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

• 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, industry related seminars, forums, or conventions, etc.
• BS Degree in Engineering or related technical degree.

Additional information

Our culture and commitment to our people is what sets us apart. We foster an environment of mutual respect, integrity, and unconditional interest in the individual and collective success of our professionals. Our model and entrepreneurial mindset offer a rewarding, challenging, and highly flexible path.

As a Validation Project Manager, you will build a meaningful and fulfilling career with the support of professional development resources and mentorships including our First Year Experience program, Individual Development Plans, and Career Path resources and tools. You will be surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader.

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At Barry-Wehmiller we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions.

Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.