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Equipment Validation Engineer

Summit, NJ 07901

Posted: 07/25/2023 Job Number: 24550481

Job Description

100% Onsite Required .
Must have: Experience Developing Validation/Qualification Deliverables: Validation Plans, Requirement Specifications, Traceability Matrices, Summary Reports, Change Controls .

Pay ranges between $74.35 - $79.27/hr W2.

Required Skills:
  • BS in Engineering or Science related discipline required .
  • 5 years' experience performing/supporting activities in a GMP environment.
  • 3 years' experience in Equipment, Facility or Utility Qualification.
  • Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
  • Experience in the qualification of cell therapy equipment a plus .
  • Advanced knowledge of pharmaceutical, manufacturing and laboratory systems.
  • Understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry.
  • Strong written and verbal communication skills.
  • Excellent interpersonal skills with experience dealing with a diverse workforce.
  • Strong multi tasking ability in conjunction with proven organizational skills.
  • Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion.
  • Ability to effectively manage multiple tasks and activities simultaneously.
  • Highly proficient computer skills in Microsoft Office Suite Word, Excel, PowerPoint, and Outlook with extensive background in database systems.
  • Innate ability to learn new software, such as corporate intranet and enterprise business.

Project Description:
  • The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers.
  • The incumbent in this is tasked with commissioning and qualifying new equipment facilities, utilities and maintaining equipment systems in a qualified / validated state according to established policies and procedures.
  • The individual participates in projects and ongoing work activities of low to moderate complexity.
  • With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope.
  • As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate
  • Maintains qualified equipment systems in compliance with policies, guidelines, and procedures .
  • Develops qualification protocols, and associated reports while adhering to a change management process.
  • Supports the execution of equipment qualifications and validation protocols.
  • Supervises vendors for qualification functions.
  • Develops written procedures for calibration and preventive maintenance of equipment.
  • Supports equipment qualification and validation activities.
  • Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.
  • Manages projects of limited scope and complexity within their functional area .
  • Supports equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turnover to business area.
  • Supports internal customer groups in the procurement, operation, calibration, and
    preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.
  • Completes all qualification and validation documentation with accuracy, completeness, and compliance with company standards.
  • Provides excellent customer service and support .
  • Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests.
  • Provides technical support and guidance on equipment qualification issues. Interfaces with customers to ensure all expectations are being met.
  • Provides technical support and guidance on equipment and computer systems qualification and validations issues.
  • Maintains a positive relationship with all team members and site customers while promoting a positive team environment.
  • Ensure equipment, facilities and programs are maintained in compliance.
  • May be called upon as SME in both internal and regulatory audits.

  • Physical / Mental Demands:
    • Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs .
    • Ability to sit, stand, walk, and move within workspace for extended periods .
    • Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing, and pulling.
  • Environmental Conditions:
  • Primarily office environment but will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes.
  • Ability to work safely and effectively when working alone or working with others.

This 6+month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Loren: loren@alphaconsulting.Com


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Loren Graham

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