Regulatory Compliance Specialist

1 day ago


Frederick, Maryland, United States Precision Medicine Group Full time
About Us

Precision Medicine Group is a leading advanced therapy technical operations consulting company in the life science industry. We are committed to advancing manufacturing to achieve operational excellence and accelerate speed to market for next-generation medicines.

Role Overview

We are seeking an experienced Validation Engineer to join our dynamic team. As a key member of our engineering group, you will be responsible for ensuring the accuracy and reliability of our clients' manufacturing processes.

Key Responsibilities:
  • Create alignment with cross-functional client departments including but not limited to Validation, Manufacturing, Quality, Supply Chain, and Engineering.
  • Provide hands-on support and troubleshooting for clients navigating the engineering life cycle of cutting-edge equipment and manufacturing processes.
  • Perform due diligence on system and subject domains to generate high-quality project deliverables.
  • Author technical documents such as SOPs, requirements specifications, testing protocols, summary reports, etc.
  • Execute system and process validation protocols using GxP best practices.
Qualifications:
  • Bachelor's degree in Life Science, Engineering, or related discipline and/or comparable military experience.
  • Covid Vaccine required prior to the Team Member's start date with exceptions for medical and religious accommodations when reasonable.
  • Full time on-site client presence.
  • Willingness to travel up to 100% or as required to support project and business needs.
What We Offer

In return for your skills, knowledge, and passion, Precision Medicine Group offers a wide range of benefits including:

  • Competitive salary based on experience: $58,000 - $63,000 USD.
  • Aggressive bonus structure.
  • Medical, Dental, and Vision insurance effective your first day of employment.
  • 401k Plan with company match.
  • Paid Time Off and Company Paid Holidays.
  • Company Paid Maternity and Parental Leave.
  • Continuing Education Assistance.


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