Validation Manager (Design Group)
Barry Wehmiller Design Group
San Francisco, California
Expiry Date :
Tue, 15 Jun 2021 23:59:59 GMT
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Design Group operates from more than 45 offices in the United States and India, providing engineering, consulting and technical services for the worlds leading companies in the food and beverage, life sciences, advanced technology, industrial and other market sectors. Our nearly 1,500 technical and engineering experts have direct industry experience in industrial automation, control system integration, facility and process engineering, architecture, construction management, regulatory compliance, enterprise technology and other consulting services.
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.
The Validation Manager will interface with our clients and be responsible for preparing and executing commissioning and qualification documents for a variety of utility, facility and process equipment.
* Validation 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 Validation 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 Validation Manager will be responsible for developing project scope statements, estimates and proposals.
* Will work on multiple projects simultaneously
* 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
* This position 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 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.
_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 worktherefore, 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.
Design Group US Inc