Job Description
Job Description
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
- Project Manager
Description:
Provide vision and leadership to strategic projects with significant site impact. Ensure new products are launched from the site in alignment with contract goals. Manage the performance of projects or significant subsystems associated with new products by influencing, coordinating, and driving activities, initiatives, and development deliverables across cross-functional teams. Direct all phases of new product development projects from inception through completion from an Operations perspective. Lead project review sessions focusing on cost, schedule, and technical performance. Establish milestones, monitor adherence to plans and schedules, identify issues, and implement solutions. Demonstrate strong leadership, clear communication, and the ability to build effective cross-functional working relationships. Ensure Value Improvement Projects (VIP) and new product initiatives are completed in alignment with contract expectations.
Responsibilities:
- Project Planning & Definition: Define project goals, scope, resource and cost estimates, timeline, and risks. Facilitate cross-functional discussions to develop project proposals.
- People Leadership: Manage large, multi-project, multi-site cross-functional teams; provide performance input; foster strong alignment.
- Value Improvement (VIP): Oversee VIP initiatives; identify, communicate, and manage risks.
- Project / Program Management: Lead initiation, planning, execution, control, and close out activities; ensure team ownership of plans, schedules, and budgets.
- Process Management: Ensure activities follow established processes; maintain documentation discipline; reinforce VIP and NPE best practices.
- Communications & Reviews: Drive cross-functional communication; serve as liaison
- between teams and leadership; lead phase reviews; maintain documentation including minutes, issue logs, and metrics.
- New Product Excellence (NPE): Implement NPE methods; manage NPE risks and deliverables.
Experience Requirements:
- 5–7+ years of experience in manufacturing engineering or quality engineering within an FDA-regulated industry (medical devices, pharmaceuticals, biotechnology, diagnostics, or similar).
- Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), Good Manufacturing Practices (GMP), and ISO 13485.
- Experience supporting new product introductions (NPI/NPD), including process development, equipment qualification, and process validation.
- Hands-on experience with risk management (FMEA, hazard analysis), root cause investigations, and CAPA systems.
- Proven collaboration with Operations, Quality Assurance, Regulatory, R&D, and Supply Chain teams.
- Familiarity with controlled documentation systems, engineering change processes, and manufacturing readiness requirements.
- Experience ensuring compliance with quality system procedures and regulatory expectations across the project lifecycle.
- PMP Certification is strongly recommended
The above statements describe the general nature and level of work performed and do not represent an exhaustive list of responsibilities. Training requirements are established and tracked through the individual learning plan. For physical requirements, consult the local Environmental Health & Safety (EHS) team. Support a work environment aligned with EHS and Energy Policies.
At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.