Sr. Validation Project Manager (Life Sciences)

Barry-Wehmiller Companies Inc.; Santa Ana (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Barry-Wehmiller Companies Inc. seeks a Sr. Validation Project Manager for our Design Group in Santa Ana, CA. You will lead validation teams, interface with clients, and drive regulatory compliance across utility, facility and process systems.

You will bring 7+ years in validation and project management within FDA-regulated environments, with strong leadership, documentation, and risk-management skills. Travel to client sites is expected as needed.

Qualifications

• Minimum of 7 years’ experience with increasing responsibility in validation/quality service and project management of life sciences, biotech or other FDA regulated projects.
• This position requires 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.
• Project Management experience in managing scope, cost, schedule, quality, and risk is required.

Responsibilities

• Sr. Project Manager will 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.
• Lead business development efforts in the region related to engaging with new clients in the life sciences sector and expanding engagements with existing clients.
• Develop project scope statements, estimates and proposals; manage multiple projects simultaneously.

Skills

Project management

Leadership

Verbal communication

Technical writing

Risk assessment

cGMP

FDA validation

Quality by Design

Reading engineering docs

Mentorship

Travel readiness

Education

BS in Engineering

Tools

Microsoft Word

Excel

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

Sr. Validation Project Manager

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 Sr. 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

• Sr. Project Manager will 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. The Sr. Project Manager will 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 The Sr. Project Manager will be responsible for developing project scope statements, estimates and proposals. Will work on multiple projects simultaneously Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team

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.
• This position requires 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 and
• Requires 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 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.

Approximate Pay Range

The approximate pay range for this position is $120k-$160k. Please note that the pay range provided is a good faith estimate for the position at the time of posting. Final compensation may vary based on factors including but not limited to background, knowledge, skills, and abilities as well as geographic location of the position.

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

Throughout Barry-Wehmiller, we hold ourselves to a unique measure of success: by the way we touch the lives of people. It’s that vision that drives us in creating world-class experiences and solutions for our customers and unites us around our common goal—to use the power of our business to build a better world.