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Project Manager

2 weeks ago

Indianapolis, IN, United States Validation & Engineering Group Inc. Full time
Validation & Engineering Group, Inc. (V&EG) 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
Job Summary:

We are looking for a Project Manager with hands-on experience in Validation to provide full oversight of equipment qualification activities. This role will focus on Autoclaves, Fillers, and Partwashers within a regulated manufacturing environment. The ideal candidate will be responsible for coordinating all validation tasks, identifying next steps, and ensuring alignment across teams and vendors. Safety knowledge is a plus.

Key Responsibilities:
  • Provide full oversight and coordination of validation projects for Autoclaves, Fillers, and Partwashers.
  • Act as the central point of contact for all activities related to equipment qualification.
  • Coordinate cross-functional teams to ensure timely execution of project milestones.
  • Continuously assess project status and determine what is needed for upcoming activities.
  • Lead planning and scheduling of validation tasks including URS, FAT/SAT, IQ, OQ, and PQ.
  • Ensure compliance with cGMP, FDA, and internal quality and documentation standards.
  • Track timelines, manage risks, escalate issues, and communicate progress to stakeholders.
  • Foster a strong culture of safety and ensure safety practices are integrated into all project activities.
Qualifications:
  • Bachelor's degree in Engineering, Life Sciences, or a related field.
  • 5+ years of experience in validation and project coordination within pharmaceutical or regulated environments.
  • Proven experience qualifying Autoclaves, Fillers, and Partwashers.
  • Strong understanding of validation documentation and regulatory compliance (GMP, FDA).
  • Excellent coordination, planning, and leadership skills.
  • Safety certification or demonstrated safety awareness is a plus.

Schedule: Full-time, on-site in Indianapolis, IN