Principal Quality Engineer; Laboratory & Validation

Principal Quality Engineer (Laboratory & Validation)

Base pay range: $95,000.00/yr - $/yr

We are looking for a Principal Quality Engineer to support laboratory operations, equipment validation, and compliance in a GMP/GxP environment. This is a highly visible, hands‑on role for an experienced engineer who enjoys ownership, accountability, and technical depth.

• Fully onsite in Marietta, GA
• Standard full‑time schedule (core hours: 8:00am–5:00pm)
• No relocation assistance provided

This role owns the full lifecycle of laboratory equipment, including installation, qualification, requalification, validation, monitoring, documentation, and audit readiness. The Principal Quality Engineer acts as the technical and compliance subject matter expert for laboratory systems and equipment, supporting cross‑functional teams and mentoring junior engineers. This is not a desk‑only role — it is hands‑on, technical, and documentation‑driven, with strong interaction across Engineering, Quality, IT/CSV, and laboratory teams.

• Own and manage laboratory equipment lifecycle activities including installation, qualification, requalification, validation, and retirement.
• Design, execute, and document equipment qualifications, requalifications, and process validations in accordance with GMP and regulatory standards.
• Perform and support temperature mapping, continuous monitoring, alarm investigations, and sterilizer/autoclave qualifications.
• Analyze raw validation and qualification data and generate formal reports.
• Support internal and external audits by ensuring documentation is accurate, complete, and inspection‑ready.
• Author and maintain quality documentation including protocols, reports, deviations, CAPAs, change controls, and risk assessments.
• Collaborate with IT and CSV teams on validation of systems that generate electronic data (Part 11 compliance).
• Serve as the technical point of contact for equipment vendors and service providers.
• Train and mentor junior engineers and laboratory associates on equipment use, processes, and compliance.
• Identify trends, investigate failures, and drive proactive improvements to equipment performance and compliance.
• Participate in cross‑site and cross‑functional process alignment and continuous improvement efforts.

• Bachelor’s degree in Engineering or a related scientific discipline (Master’s preferred).
• 8–10 years of experience in engineering, validation, or quality within a regulated environment.
• Strong experience in GMP / GxP regulated industries (pharmaceutical, biotech, medical device, or CRO).
• Hands‑on experience with equipment qualification, validation, and requalification.
• Experience supporting regulatory inspections and audits.
• Strong technical writing skills (protocols, reports, deviations, CAPAs).
• Ability to manage multiple priorities, work independently, and mentor others.
• Excellent attention to detail, organization, and documentation practices.
• Ability to work fully onsite.

• Experience with building automation or continuous monitoring systems.
• Experience with equipment management or maintenance systems.
• Familiarity with 21 CFR Part 11, 21 CFR Part 820, ISO standards.
• Experience with laboratory or testing environments.
• Experience with temperature mapping, incubators, sterilizers, or autoclaves.

• This role involves frequent standing, walking, and hands‑on work with equipment.
• Ability to lift up to 50 lbs as needed.
• Requires close attention to detail and the ability to work in active laboratory environments.

Important Note: Must be able to pass a background check and drug screen.

• High ownership and technical autonomy
• Opportunity to act as a site‑level subject matter expert
• Strong team culture focused on integrity, accountability, and collaboration
• Long‑term stability in a regulated, high‑impact environment

• Seniority level:
  Mid‑Senior level
• Employment type:
  
  Full‑time
• Job function:
  Quality Assurance, Engineering, and Manufacturing
• Industries:
  Biotechnology Research, Pharmaceutical Manufacturing, Medical Equipment Manufacturing