Project Manager, Validation

barrywehmiller; East Brunswick Township (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Design Group, part of Barry-Wehmiller, seeks a Project Manager, Validation in New Jersey to lead pharma/medical device validation programs for major clients. You will join a team of industry experts and coordinate with operations, quality, and regulatory functions to ensure compliant, on-time deliverables.

The role emphasizes hands-on documentation (FAT, SAT, IQ, OQ), on-site leadership, and building strong client relationships while traveling as needed.

Qualifications

• Bachelor’s degree in Chemical, Biomedical, Electrical, Mechanical engineering or equivalent.
• 10+ years of validation experience in pharma or medical device processes and equipment.
• FAT, SAT, IQ and OQ documentation development and execution for automated systems.
• Strong leadership and communication skills across management, clients, and vendors.
• Willingness to travel as required for project needs.

Responsibilities

• Prepare, execute commissioning and qualification documents for validation projects (equipment, process, and systems).
• Lead and manage a diverse portfolio of validation projects simultaneously.
• Develop validation and FDA compliance related documents/protocols.
• Serve as the primary on-site point of contact and local engineering leader for major pharma manufacturing clients.
• Build and maintain relationships with client stakeholders across operations, quality, regulatory, and executives.
• Collaborate with cross-functional teams to deliver high-quality, compliant solutions.

Skills

Validation leadership

Pharma validation

Regulatory compliance

Client relations

Communication skills

Travel readiness

Team leadership

Documentation skills

Education

Bachelor's degree in Chemical Engineering

Biomedical Engineering

Electrical Engineering

Mechanical Engineering

Equivalent technical degree

Tools

Computer systems validation

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, Validation

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.

• Responsible for preparing, executing commissioning and qualification documents for a variety of utility, facility, and process equipment.
• Lead and manage a diverse portfolio of validation projects simultaneously (equipment qualification, process validation, cleaning validation, system digitization, etc.)
• Develop and execute a variety of validation and FDA compliance related documents/protocols for pharmaceutical equipment.
• Serve as the primary on-site point of contact and local engineering leader for major pharmaceutical manufacturing clients
• Build and maintain strong relationships with client stakeholders across operations, quality, regulatory, and executive levels
• Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team

What You’ll Bring

• Minimum 10+ years of demonstrated experience with validation of pharmaceutical or medical device processes and equipment
• FAT, SAT, IQ and OQ documentation development and execution on Automated Systems in the Pharmaceutical Industry
• Validation experience in the areas of automation, packaging, cleaning, Computer systems, utilities and/or facilities is desired
• Excellent leadership skills including the ability to simultaneously organize, and successfully execute multiple project responsibilities
• Candidates need to possess good communication and interpersonal skills and the ability to interact with all levels of management, clients, and vendors.
• Strong computer skills are also required
• 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.
• Bachelor’s degree in Chemical Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering or equivalent 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 Sr. Validation Engineer, 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.

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