Planet Pharma · 1 hour ago
Quality Engineer II
Hunt Valley, MD
Full-time
Onsite
Senior Level
$30/hr - $35/hr
5+ years expPlanet Pharma is seeking a Quality Engineer II to manage a high-volume workload of high-accuracy equipment, ensuring compliance with ISO and regulatory standards. The role involves calibration, technical troubleshooting, and documentation management to support complex process control systems.
BiotechnologyHealth CarePharmaceutical
Hiring Manager
Patrick Sazama
Responsibilities
Precision Calibration: Adjust, test, and certify a wide range of equipment including temperature controllers, autoclaves, benchtop multimeters, tachometers, volt meters, and generators
System Support: Manage calibrations for complex process systems that may contain 4–5 integrated instruments
Data & Documentation: Utilize Blue Mountain RAM (BMRAM) to track asset data, manage work orders, and document reports
Technical Troubleshooting: Investigate measurement inaccuracies, resolve equipment errors, and identify deviations to recommend corrective actions
Compliance: Maintain meticulous records in alignment with GMP and ISO traceable standards
Qualification
Required
NO PhD CANDIDATES WILL BE CONSIDERED FOR THIS POSITION
6 Month Contract (May extend or convert to permanent)
Manage a high-volume workload of high-accuracy equipment, ensuring every instrument—from pressure gauges to safety analyzers—meets strict ISO and regulatory standards
Precision Calibration: Adjust, test, and certify a wide range of equipment including temperature controllers, autoclaves, benchtop multimeters, tachometers, volt meters, and generators
System Support: Manage calibrations for complex process systems that may contain 4–5 integrated instruments
Data & Documentation: Utilize Blue Mountain RAM (BMRAM) to track asset data, manage work orders, and document reports
Technical Troubleshooting: Investigate measurement inaccuracies, resolve equipment errors, and identify deviations to recommend corrective actions
Compliance: Maintain meticulous records in alignment with GMP and ISO traceable standards
Experience: 5–10 years of dedicated experience in a calibration setting
Specialized Training: Strong preference for candidates with TDME (Test Method Diagnostic Equipment) or Precision Medicine Equipment Lab (PMEL) training
Temperature: Experience ranging from -20C to 150C
Voltage: Expertise from 0 to 1000V
Equipment: High-accuracy tools, faciloscopes, generators, and safety analyzers
Bachelor's degree in Mechanical or Electrical Engineering (preferred)
Associate's Degree (AS) will be strongly considered if accompanied by heavy, high-level calibration experience
Software: Proficiency in calibration software; specific training on Blue Mountain RAM will be provided if needed
Preferred
Background in GMP (Good Manufacturing Practice) environments
Proven ability to pivot between different equipment types (e.g., multimeters one day, pressure gauges the next) based on the calibration schedule
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