Barry-Wehmiller · 3 months ago
Sr. Validation Project Manager (Life Sciences)
Santa Ana, CA USA
Full-time
Onsite
Senior Level
$120K/yr - $160K/yr
7+ years expBarry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology. As a Sr. Validation Project Manager, you will lead teams of validation professionals, interface with clients, and develop project scope statements while supporting capital projects in the life sciences sector.
Machinery
Responsibilities
You'll work individually and in teams to support capital projects and implement solutions for our clients
The 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
Qualification
Required
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
Experience with system and process risk assessments; including FMEA, HAZOP and Fault Tree Analysis
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
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
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
BS Degree in Engineering or related technical degree
Preferred
Strong understanding of EPCMV, Quality by Design and risk-and science-based approaches for compliance
Experience with system and process risk assessments; including FMEA, HAZOP and Fault Tree Analysis
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
Benefits
Professional development resources
Mentorships
First Year Experience program
Individual Development Plans
Career Path resources and tools
Company
Barry-Wehmiller
We’re Building A Better World. We’re more than just a successful capital equipment and engineering solutions firm.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Bob Chapman
CEO and Chairman
Doug McGraw
President & CEO, BW Flexible Systems
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