Indianapolis, Indiana, United States · On-site
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 Commerc…
Skills: Project Management, Validation, Commissioning, Qualification, cGMP
Green Bay, Wisconsin, United States · Remote OK
About Us: 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 leade…
Skills: Mechanical troubleshooting, Equipment installation, Preventive maintenance, Die-cutting, Folding
Green Bay, Wisconsin, United States · Remote OK
About Us: 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 leade…
Skills: Electro-mechanical troubleshooting, Machine installation, PLC programming, Servo control systems, Technical training
Waukesha, Wisconsin, United States · On-site
About Us: BW Converting is a strategic alliance of resources and services that bring together several Barry-Wehmiller companies — Paper Converting Machine Company (PCMC), Winkler + Dünnebier (W+D), STAX Technologies, Hud…
Skills: Leadership, Electrical Engineering, Software Engineering, Resource Allocation, Project Management
Indianapolis, Indiana, United States · On-site
About Us: Alliance Machine Systems International, LLC is a privately held company with over 35 years of history dedicated to providing corrugated box manufacturing machines and services to the changing industry. As the p…
Skills: Procurement, Sourcing, MRP/ERP Systems, Supply Chain Management, Negotiation
Spokane, Washington, United States · On-site
$80k–$95k/yr
About Us: Alliance Machine Systems International, LLC is a privately held company with over 35 years of history dedicated to providing corrugated box manufacturing machines and services to the changing industry. As the p…
Skills: Production supervision, Leadership, Operations management, Mechanical aptitude, Strategic thinking
Neuwied, Rhineland-Palatinate, Germany · On-site
Abteilung Information: BW Converting ist eine strategische Allianz von Ressourcen und Dienstleistungen, die die folgenden sechs Barry-Wehmiller-Unternehmen zusammenbringt: Paper Converting Machine Company (PCMC), Winkler…
Skills: Program management, Stage-gate process, New product development, Cross-functional team leadership, Stakeholder management
Sleepy Eye, Minnesota, United States · On-site
$20/hr–$24/hr
About Us: Afinitas, headquartered in St. Louis, Missouri, is a global leader in equipment, forming systems, and essential accessory products that support transportation, water, and utility precast concrete infrastructure…
Skills: Welding, Steel fabrication, Forklift operation, Hand tools, Mathematics
Alpharetta, Georgia, United States · On-site
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 Commerc…
Skills: Project controls, Schedule analysis, Cost control, Change management, EPC projects
Lucca, Tuscany, Italy · On-site
Informazioni sulla Divisione: BW Converting è un'alleanza strategica di risorse e servizi che riunisce sei aziende Barry-Wehmiller: Paper Converting Machine Company (PCMC), Winkler + Dünnebier (W+D), STAX Technologies, H…
Skills: Electro-mechanical troubleshooting, Machine installation, PLC programming, Servo control systems, Web handling
Baltimore, Maryland, United States · On-site
About Us: BW Papersystems, part of the Barry-Wehmiller Group, builds capital equipment that transforms paper into products for consumers - every day, around the world. We offer innovative technologies, service and parts,…
Skills: Mechanical assembly, Blueprint reading, Component alignment, Machine erection, Technical drawing interpretation
Green Bay, Wisconsin, United States · On-site
About Us: 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 leade…
Skills: Root Cause Corrective Action, 3 Legged 5 Why, GD&T, PPAP, PFMEA
Los Angeles, California, United States · On-site
$75k–$85k/yr
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 Commerc…
Skills: Project management, Mechanical design, Line layout engineering, Vendor management, Contractor management
Clayton, Missouri, United States · On-site
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 Commerc…
Skills: Architectural design, Construction documents, Building envelope systems, Code research, Revit
Akron, Ohio, United States · On-site
About Us: BW Packaging is driving performance at the intersection of people, technology, and customer care. As part of the privately held Barry-Wehmiller family, we unite a global team of packaging experts with a clear p…
Skills: Preventative maintenance, Troubleshooting, Mechanical repair, Electrical repair, Pneumatic systems
Eau Claire, Wisconsin, United States · Hybrid
About Us: 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 leade…
Skills: 3D CAD, SolidWorks, Autodesk Inventor, Mechanical Design, Machine Component Design
Eau Claire, Wisconsin, United States · Hybrid
About Us: 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 leade…
Skills: Electrical engineering, CAD, AutoCAD Electrical, Eplan, PLC
Fresno, California, United States · On-site
$70k–$100k/yr
About Us: 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 leade…
Skills: Network Infrastructure, Troubleshooting, Firewall Configuration, Router Configuration, Switch Configuration
St. Louis, Missouri, United States · On-site
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 Commerc…
Skills: Shipping, Receiving, Logistics, Warehouse Operations
United States · Remote Solely
$111k–$167k/yr
About Us: 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 leade…
Skills: ERP Implementation, Business Process Mapping, Requirements Gathering, Gap Analysis, Project Cost Management
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The Project Manager will lead validation teams and manage the full project life cycle for capital projects in the life sciences sector. They are responsible for developing project scopes, ensuring regulatory compliance, and interfacing with clients to deliver high-quality technical solutions.
Candidates must have a minimum of 7 years of experience in validation and project management within FDA-regulated industries. A Bachelor's degree in Engineering or a related technical field is required, along with strong leadership and technical documentation skills.
Project Manager, CQV
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
· Additional Job Description
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.
We’re Building A Better World. We’re more than just a successful capital equipment and engineering solutions firm. We’re an organization fiercely committed to improving the lives of our team members across the globe. By providing meaningful work in an environment of care and compassion, we send them home fulfilled by their time with us, rather than drained by it. We understand what every human being on the planet desires: to know that who they are and what they do matter. As a business, we have a unique opportunity to let them know that they do. Through our Truly Human Leadership culture and personal growth initiatives, we help them become their best selves. And when we bring out their best, they give their best. To their work, their team members and friends, our customers and suppliers, the people in the communities in which they work and live, and--most important of all--to their families. And before you know it, a better job has helped build a better world!
Offices: 8020 Forsyth Blvd, Saint Louis, MO 63105, US
We’re Building A Better World. We’re more than just a successful capital equipment and engineering solutions firm. We’re an organization fiercely committed to improving the lives of our team members across the globe. By providing meaningful work in an environment of care and compassion, we send them home fulfilled by their time with us, rather than drained by it. We understand what every human being on the planet desires: to know that who they are and what they do matter. As a business, we have a unique opportunity to let them know that they do. Through our Truly Human Leadership culture and personal growth initiatives, we help them become their best selves. And when we bring out their best, they give their best. To their work, their team members and friends, our customers and suppliers, the people in the communities in which they work and live, and--most important of all--to their families. And before you know it, a better job has helped build a better world!
Offices: 8020 Forsyth Blvd, Saint Louis, MO 63105, US
