Sr. Validation Project Manager (Life Sciences)
About The Position
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. 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. 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.
Requirements
- 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.
- Requires strong leadership, verbal communication, technical writing, project management tools and word processing skills.
- 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.
Nice To Haves
- 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
- 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.
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.
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Professional, Scientific, and Technical Services
Number of Employees
5,001-10,000 employees
