Equipment Engineer
Company: Joul--
Location: Warren
Posted on: April 17, 2025
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Job Description:
Job Title: GMP Equipment Support Engineer - Laboratory &
Manufacturing
Do not wait to apply after reading this description a high
application volume is expected for this opportunity.
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 Execute calibration, preventative maintenance,
qualification, troubleshooting, and repair of laboratory and
manufacturing equipment using CMMS (e.g., Blue Mountain RAM or
Maximo).
Supervise and review vendor-performed maintenance, calibration, and
verification activities.
Author, revise, and maintain SOPs, calibration and maintenance
plans, and performance verification protocols.
Support quality systems by owning and resolving deviations,
investigations, CAPAs, and change controls.
Perform requalification of Controlled Temperature Units (CTUs) such
as refrigerators, freezers, cryotanks, and storage rooms.
Participate in process improvement initiatives and cost-reduction
projects.
Collaborate with cross-functional teams (QC, QA, Manufacturing,
Engineering, Facilities) and external vendors.
Ensure compliance with GMP, GXP, GAMP, and 21 CFR Part 11 standards
and documentation practices.
Provide on-call equipment support during weekends and support
multiple site locations (Warren and Summit).
Maintain proper documentation and data integrity in accordance with
ALCOA+ principles.
Participate in audits and act as Subject Matter Expert (SME) when
required.
Requirements Bachelor's degree in Engineering or a Science-related
discipline preferred.
Minimum 3 years of experience in an FDA-regulated or clinical
environment.
Hands-on experience with lab equipment (e.g., centrifuges,
balances, temperature/humidity meters, freezers,
refrigerators).
Familiarity with calibration management and environmental
monitoring systems.
Proficient in Microsoft Office Suite; ability to learn enterprise
systems and scheduling/inventory tools.
Strong critical thinking, multitasking, and organizational
skills.
Excellent communication and interpersonal abilities with a
collaborative mindset.
Knowledge of CMMS platforms such as Blue Mountain RAM or Maximo
preferred.
Experience with maintenance planning and coordination is a
plus.
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
Keywords: Joul--, Camden , Equipment Engineer, Engineering , Warren, New Jersey
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