Equipment Engineer

Katalyst HealthCares and Life Sciences

• $95K — $115K *
Summit, NJ 07901In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering or a related science field is preferred; equivalent experience may suffice.
  • At least 5 years in a GMP environment related to equipment or facilities support.
  • Minimum of 3 years specifically focused on equipment, facilities, or utilities qualification.
  • Knowledgeable in regulatory guidelines including cGMP, GxP, GAMP, and 21 CFR Part 11.
  • Strong skill set in investigations, deviation management, and CAPA processes in regulated environments.

Responsibilities

  • Maintain compliance of commissioned/qualified equipment and utilities according to established procedures.
  • Develop and document commissioning/qualification protocols and supporting reports.
  • Oversee vendor qualification activities effectively.
  • Aid in crafting operational procedures for equipment use.
  • Execute and support equipment qualification and validation processes rigorously.
  • Create comprehensive deliverables for validation and qualification activities, such as Validation Plans and Summary Reports.
  • Facilitate equipment implementation projects from scheduling to turnover.

Benefits

  • Collaborative team culture with strong internal and vendor support.
  • Opportunity to engage with cutting-edge equipment and systems in a GMP setting.
  • Professional development opportunities related to compliance and qualification processes.
Full Job Description
Job Summary:
  • The Equipment Engineer (Equipment Commissioning & Qualification - ECQ) supports the successful implementation, commissioning, qualification, and maintenance of equipment, instruments, facilities, and utilities in a GMP-regulated pharmaceutical environment.
  • The role is responsible for ensuring equipment remains in a commissioned, qualified, and validated state while supporting equipment implementation projects, qualification activities, compliance, and collaboration with internal teams and external service providers.
Roles & Responsibilities:
  • Maintain commissioned/qualified equipment, facilities, and utilities in compliance with policies, guidelines, and procedures.
  • Develop commissioning/qualification protocols and associated reports while adhering to change management processes.
  • Supervise vendors performing qualification activities.
  • Support the development of equipment operational procedures.
  • Support equipment validation activities and execute equipment qualification and validation protocols.
  • Develop validation and qualification deliverables, including Validation Plans, Requirements Specifications, Design Specifications, Traceability Matrices, and Summary Reports.
  • Support the Change Management process.
  • Support equipment implementation projects, including scheduling, site preparation, installation, qualification, and turnover to business.
  • Support operation, calibration, and preventive maintenance of equipment to meet business requirements.
  • Complete qualification and validation documentation accurately and in compliance with client standards.
  • Review, prioritize, and respond to customer equipment qualification and support requests.
  • Provide technical support and guidance on equipment qualification issues.
  • Interface with customers to ensure expectations are met.
  • Provide technical support for equipment, utilities, facilities, and computerized systems qualification and validation issues.
  • Maintain positive working relationships with team members and site customers.
  • Ensure equipment, facilities, and programs remain compliant with regulatory requirements.
  • Participate in deviation investigations as a Subject Matter Expert (SME), when required.
Education & Experience:
  • BS in Engineering or Science related discipline preferred; equivalent relevant experience may be considered.
  • Minimum of 5 years of experience performing or supporting activities in a GMP environment.
  • Minimum of 3 years of experience in equipment, facilities, or utilities qualification.
  • Knowledge of cGMP, GxP, GAMP, SDLC, 21 CFR Part 11, Computer System Validation (CSV) requirements, and Good Documentation Practices.
  • Knowledge of pharmaceutical manufacturing and laboratory systems.
  • Understanding of investigations, deviations, and CAPA management in a regulated pharmaceutical environment.
  • Strong written, verbal, interpersonal, organizational, and multitasking skills.
  • Detail-oriented with a strong commitment to quality, safety, and compliance.
  • Ability to manage multiple projects and prioritize tasks effectively.
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and database systems.
  • Experience with Electronic Data Management Systems such as ValGenesis is preferred.
* Ladders Estimates

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