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Equipment Qualification Engineer

Equipment Qualification Engineer

SPECTRAFORCEMillburn, NJ, US
Hace 1 día
Tipo de contrato
  • A tiempo completo
Descripción del trabajo

Job Description

Position Title : Equipment Qualification Engineer

Work Location : Millburn, NJ 07041

Assignment Duration : 8 Months

Work Arrangement : Onsite

This position's starting pay is : $50.00 / hr.

Position Summary : We are seeking a detail-oriented and experienced Equipment Qualification Contractor to support the qualification of laboratory equipment in compliance with cGMP and regulatory standards.

Background & Context : The contractor will be responsible for executing qualification protocols (IQ / OQ / PQ), preparing documentation, and ensuring equipment is fit for its intended use in a pharmaceutical quality control environment.

Key Responsibilities :

  • Develop, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
  • Collaborate with cross-functional teams (QC, QA, Engineering, Validation) to ensure timely and compliant equipment qualification.
  • Prepare and maintain User Requirement Specifications (URS) and Design Qualification (DQ) documentation.
  • Ensure all qualification activities are documented accurately and meet FDA, EMA, and ICH guidelines.
  • Support investigations and deviations related to equipment performance.
  • Assist in change control processes related to equipment upgrades or replacements.
  • Maintain traceability and data integrity throughout the qualification lifecycle.

Qualification & Experience :

  • Bachelor’s degree in Engineering, Life Sciences, or related field.
  • Minimum 3 years of experience in equipment qualification within a GMP-regulated pharmaceutical or biotech environment.
  • Strong understanding of Good Manufacturing Practices (GMP) and Good Engineering Practices (GEP).
  • Experience with laboratory instruments (e.g., HPLC, GC, incubators, autoclaves) and manufacturing equipment.
  • Proficiency in writing and reviewing technical documentation.
  • Excellent organizational and communication skills.

    • Preferred Skills :

  • Experience with computer system validation (CSV) and data integrity principles.
  • Ability to work independently and manage multiple priorities.
  • Notes (from Spotlight Call) :
  • This is an onsite entry-level lab role based in Millburn, NJ (North New Jersey).
  • The job mainly involves sample testing and environmental monitoring rather than administrative or documentation-heavy work.
  • The lab works with radiopharmaceutical materials, so there’s a radiation safety component. The employee will wear protective devices (like dosimeters and rings) to track exposure, but all safety precautions are in place.

    • Daily Responsibilities :

  • Perform sample testing and environmental monitoring in a GMP lab.
  • Conduct general lab housekeeping and equipment handling.
  • Work according to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
  • Handle instruments such as HPLC, pH meters, balances, and systems for endotoxin and microbial testing.
  • Use LIMS (Laboratory Information Management System) for electronic data entry.
  • Participate in batch release testing and other routine quality checks.
  • Work with both chemical and microbiological test materials (bioburden, endotoxin, viable / non-viable monitoring).

    • Qualification & Background :

  • Degree in Chemistry, Biology, or Microbiology (or other science-related fields).
  • 2–3 years of experience preferred, but HM is also open to candidates with more or even slightly less experience (including proactive recent grads).
  • Must understand GMP documentation and how to work in a regulated lab setting.

    • Top 3 Skills HM is Looking For :

  • Experience with GMP or lab documentation.
  • Proactiveness – someone who can take direction and execute tasks independently.
  • Team player – cooperative and adaptable in a team setting.

    • Technical Tools / Instruments Used :

  • HPLC (High-Performance Liquid Chromatography)
  • Endoscan for endotoxin testing
  • LIMS for data management
  • Air samplers & particle counters for environmental monitoring
  • pH meters, balances, etc.

    • Other Key Points :

  • The role focuses more on routine batch release testing rather than method validation or method transfer work.
  • Flexibility in background – candidates from both analytical and microbiology backgrounds are welcome.
  • HM prioritizes mindset and GMP awareness over very specific technical expertise since technical skills can be trained.

    • Applicant Notices & Disclaimers

  • For information on benefits, equal opportunity employment, and location-specific applicant notices, click here

    • At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.

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    Equipment Engineer • Millburn, NJ, US

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