Planet Pharma · 2 hours ago
Principal Quality Engineer (Laboratory & Validation)
Marietta, GA
Full-time
Onsite
Lead/Staff
$95K/yr - $110K/yr
8+ years expPlanet Pharma is seeking a Principal Quality Engineer to support laboratory operations and equipment validation in a GMP/GxP environment. This hands-on role involves managing the lifecycle of laboratory equipment, ensuring compliance, and mentoring junior engineers while collaborating with cross-functional teams.
BiotechnologyHealth CarePharmaceutical
Hiring Manager
Jackie Raimondi
Responsibilities
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
Qualification
Required
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
Preferred
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
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase