Validation Project Manager
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Apply Now Application ends in 19d 22h 19min
Job Detail
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Offered Salary 0
Job Description
Your Role
We are excited to accept applications for future opportunities. Join our talent pool for future openings by applying now. This is a W2-Temp 6-month role with potential FTE extension. We are hiring an experienced and motivated Validation Project Manager to plan, execute, and manage CQV projects, manage vendors, and provide technical execution review. This role will drive successful project and deliverable completion adhering to industry standards and regulations.Â
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- Drive project success by assessing priorities and project plans, schedule, and budget, and ensure timely and effective resolution of potential risks and issues.Â
- Assist in the development of CQV project planning in accordance to project design documentation, equipment specifications, etc.Â
- Identify and develop the scope of work required per systems (including loop checks, hardware check-outs, other related CQV tasks).Â
- Oversee and track the development of user requirements documentation on a system-by-system basis.Â
- Collaborate with technical teams, contractors, and equipment vendors to develop system lists and system boundaries.
- Coordinate instrument and equipment checkout activities.Â
- Oversee calibration requirements with instrumentation contractors.Â
- Serve as liaison between vendors and contractors, coordinating required hand-offs.Â
- Manage and review vendor contracts (review timesheets, earned value, project scope changes, etc.)Â
- Support the development of proposal writing for contracting and CQV resources.Â
- Ensure effective and active communication with stakeholders, project managers, on all project updates, progress, risks, resolutions, budget, contractor and vendor statuses, change requests, and so on.Â
- Elevate any potential risks or issues to upper management and determine any potential delays in deliverables.Â
- Ensure all required documentation is recorded in a timely and efficient manner, and meets regulatory and quality guidelines.Â
- Lead meetings with project managers and team members as needed.Â
Requirements
- Bachelor’s degree in engineering or related technical field.Â
- 10+ years of CQV experience in a regulated GMP environment.Â
- Experienced with facility build-out requirements and project planning.Â
- Experience managing equipment and instrumentation contractors and vendors.
- Experience supporting proposal writing.Â
- Strong understanding of regulatory requirements (FDA, EMA, ICH, etc.) and industry standards (GMP, GLP, GAMP, etc.) related to CQV.
- Experience with risk assessment methodologies (e.g., FMEA) and root cause analysis.
- Excellent project management skills, including the ability to develop and manage project plans, schedules, and budgets.
- Exceptional attention to detail and the ability to review technical documentation thoroughly.
- Effective communication and interpersonal skills, enabling collaboration with diverse cross-functional teams.
- Travel is required. At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.
Apply Now
Application ends in 19d 22h 19min