Project Manager, CQV

BW Design Group; Indianapolis (IN); On-site; USD 110,000 - 165,000; Full time

Job summary

BW Design Group is seeking a Validation Project Manager to lead teams in validation/quality service for life sciences projects. You will interface with clients, develop project scope, estimates, and proposals, and guide commissioning, qualification, and validation activities.

We value leadership, strong communication, and a track record of delivering compliant solutions under cGMP and FDA methods. Occasional travel to client sites will be required as projects demand.

Qualifications

• Bachelor's degree in engineering or a related technical field.
• Minimum 7 years in validation/quality service and project management in life sciences or FDA-regulated projects.
• Experience with EPCMV, Quality by Design, data integrity, 21 CFR Part 11.
• Ability to travel as necessary for project requirements.

Responsibilities

• Lead validation teams and interface with clients on projects.
• Develop scope statements, estimates, and proposals.
• Manage multiple projects simultaneously from planning to delivery.
• Provide Subject Matter Expert guidance in commissioning, qualification, and validation.
• Mentor teams and coordinate external consultants.

Skills

Project Management

Validation & QA

FDA Validation Methods

cGMP

Risk Assessment (FMEA/HAZOP)

Leadership

Client Communication

Documentation & GMP Records

Process Equipment Validation

Education

BS Degree in Engineering or related technical degree

Job description

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

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.

Additional Job Description

• Coordinates work activities of multiple functional areas to ensure satisfactory delivery of assigned projects.
• Responsible for all aspects of the project life cycle: planning, scope definition, design, execution, and delivery.
• Tracks progress against milestones, budgetary guidelines, or other performance indicators and prepares and delivers reports to management.
• Selects, negotiates with, and manages activities of external consultants or vendors
• Other duties as assigned