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.
Director of Compliance & Validation, Life Sciences
Who You’ll Work With
You will join our East Brunswick, New Jersey office, be part of a committed organization of over 1,500 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 BW Design Group as a Director of Compliance & Validation, Life Sciences , 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.
WhatYou’llDo
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.
As the Director of Compliance & Validation, Life Sciences , you willbe responsible forleveragingtheir past professional experiences, along with BW Design Group’s engineering offering to expand our presence in the Life Science market sector in New Jersey. This role will lead a Regulatory Compliance Validation team for pharmaceutical, biotech and medical device manufacturing projects for our clients.
Weseeka passionate,high achievingprofessional who thrives in a fast-paced, collaborative, entrepreneurial environment. A leader, mentor, coach with infectious enthusiasm who lifts others to his/her level andexhibitsuncompromising dedication to client welfare.A subjectmatter expert who fully understands validation and regulatory compliance and can work with clients to develop diverse solutions to their problems. They also need to meet client needs and guide them inindustryleading best practices for complex projects that require these scope services. Activelybe involvedin the execution andleading of allphases of projects.
Lead with an uplifting entrepreneurial spirit
Inspire excellence in all aspects of performance and project execution
Display enthusiasm and excitement for client projects that lifts project teams tohigh levelsof job satisfaction
Consistentlyseeknew value-add opportunities for clients and BW Design Group
Meet with clients to define the program requirements based on an understanding of the client's production process flow and space environmental needs derived from meetings with the client and the review of any documentation provided by the client
Assess the requirements of a project, break a project into tasks, and work with teams todeterminescope of work,budgetand staffing
Communicate and interact directly with clients in a collaborative and professional manner
Create integrated solutions and communicate key concepts to the client
Develop the base plan and coordinate technical requirements with engineering disciplines
Understand and develop design intent based on clientobjectivesand provide excellent client service
Research material options to deliveran optimalsolution for the client when required by project scope
Assign and review work ofprojectteam.
Checkprogress of work and alert project leads to change of scope oradditionalservices.
Coordinate all aspects of project document completion withincompanyand externally with clients and other design professionals. Proficient written and oralcommunicationsskills.
Prepare or review budgets based on experience and scope of project.
Assistin the education and development of the team and act asresourcefor questions.
Innovate and improve design and service delivery method and processes
Build and sustainlong termclient and internal relationships
Participate actively in relevant industry organization events and conferences
Make an impact day-to-day with your skills andexpertise, strengthening that relationship with our clients and team
WhatYou’llBring
A passion for a career in the Life Science industry
15+ years of Life Science operational & engineering experience in the pharmaceutical,biotechor medical device sectors - Client side & Consulting experience highly preferred
10+ years’ experience with increasing responsibility in validation/quality service and project management of life sciences, biotech or other FDA regulated projects
Diverse experience in leading CQV 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.
Demonstrated client development experience and excellent presentation skills
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.
Experience building, managing, and leading teams
Experience withcreating proposals and business development.
Experience with financial systems,project, and client administration
Strong leadership, verbal communication, technical writing, project managementtoolsand word processing skills.
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,qualityand risk isrequired
Excellent time management skills and ability to multi-task on simultaneous projects
Travel asrequiredfor client development and project execution
Displayed leadership in a consulting and service environment.
Willing and able to travel as necessary for project requirements to include but notbe limitedto: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 arewarding, challenging, and highly flexible path. Director of Compliance & Validation, Life Sciences , 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. LI-TH1
Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.
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
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!
