What are the responsibilities and job description for the Equipment Engineer position at System One?
Location: Warren, NJ
Type: Contract
Overview
As GMP Equipment Support Engineer – Laboratory & Manufacturing, you'll ensure the smooth operation of cutting-edge lab and clinical manufacturing equipment through hands-on calibration, maintenance, and troubleshooting. This role offers autonomy, variety, and the opportunity to lead quality initiatives including deviations, CAPAs, and change controls in a highly regulated, innovative pharmaceutical environment. Ideal for detail-oriented professionals with strong technical knowledge, critical thinking skills, and a passion for cross-functional collaboration in a fast-paced, GMP-compliant setting.
Responsibilities
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Execute calibration, preventative maintenance, qualification, troubleshooting, and repair of laboratory and manufacturing equipment using CMMS (e.g., Blue Mountain RAM or Maximo).
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Supervise and review vendor-performed maintenance, calibration, and verification activities.
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Author, revise, and maintain SOPs, calibration and maintenance plans, and performance verification protocols.
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Support quality systems by owning and resolving deviations, investigations, CAPAs, and change controls.
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Perform requalification of Controlled Temperature Units (CTUs) such as refrigerators, freezers, cryotanks, and storage rooms.
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Participate in process improvement initiatives and cost-reduction projects.
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Collaborate with cross-functional teams (QC, QA, Manufacturing, Engineering, Facilities) and external vendors.
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Ensure compliance with GMP, GXP, GAMP, and 21 CFR Part 11 standards and documentation practices.
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Provide on-call equipment support during weekends and support multiple site locations (Warren and Summit).
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Maintain proper documentation and data integrity in accordance with ALCOA principles.
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Participate in audits and act as Subject Matter Expert (SME) when required.
Requirements
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Bachelor’s degree in Engineering or a Science-related discipline preferred.
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Minimum 3 years of experience in an FDA-regulated or clinical environment.
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Hands-on experience with lab equipment (e.g., centrifuges, balances, temperature/humidity meters, freezers, refrigerators).
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Familiarity with calibration management and environmental monitoring systems.
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Proficient in Microsoft Office Suite; ability to learn enterprise systems and scheduling/inventory tools.
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Strong critical thinking, multitasking, and organizational skills.
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Excellent communication and interpersonal abilities with a collaborative mindset.
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Knowledge of CMMS platforms such as Blue Mountain RAM or Maximo preferred.
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Experience with maintenance planning and coordination is a plus.
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Ability to lift up to 25 lbs, perform repetitive tasks, and work in laboratory, office, or manufacturing environments with PPE as needed.
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
Ref: #568-Clinical
