Validation Project Manager (Sr. VE)

PCMC; Indianapolis (IN); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player seeks a dynamic Project Manager Validation to join their team of experts. In this role, you will engage with leading companies in the life sciences sector, driving impactful projects that enhance operational performance. You will be part of a collaborative environment that emphasizes personal growth and professional development, working alongside seasoned leaders and technical specialists. This is an exciting opportunity to make a significant difference in the field of validation and compliance, where your contributions will help shape the future of the industry. If you are passionate about life sciences and eager to take on challenges, this position is perfect for you.

Benefits

Professional Development Resources

Mentorship Programs

Flexible Work Environment

Career Path Resources

Qualifications

• 7+ years in validation and project management for life sciences.
• Strong understanding of compliance and risk assessment methods.
• Experience leading project teams in regulated environments.

Responsibilities

• Lead validation teams and interface with clients on projects.
• Develop project scopes, estimates, and proposals.
• Coordinate multiple projects and ensure timely delivery.

Skills

Project Management

Validation/Quality Service

Documentation Practices

FDA Validation Methods

Leadership Skills

Technical Writing

Communication Skills

Risk Assessment

Education

BS Degree in Engineering

Tools

Project Management Tools

Financial Systems

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:

Who You’ll Work With

You will join one of our 45 offices in the US, be part of a committed team of over 1500 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 Project Manager Validation 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.

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.

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. Please let us know if you require reasonable accommodations during the interview process.

Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify. Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.

Company:

Design Group