02 Sep
Validation Specialist
New Jersey, Northbrunswicktownship 00000 Northbrunswicktownship USA

Description of Services (include, but are not limited to the following):
  • Lead and/or support IQ/OQ/PQ activities of new or existing equipment, and new/existing facility systems
  • Generate and execute all validation protocols (IQ/OQ/PQ) of all site equipment including lab equipment, production equipment, utilities (as applicable) and other related systems in accordance with appropriate regulatory agency validation requirements, internal company standards, and current industry best practices
  • Compile required data and perform data analysis as required per validation protocols

  • Investigate and troubleshoot problems and determine solutions
  • Prepare validation reports

  • Ensure all Validation activities are conducted in compliance with cGMP, company policies, safety standards and applicable SOPs
  • Assist in maintaining and updating the Validation Master Plan as required, to remain compliant
  • Initiate changes to assure continuous improvement of procedures
  • Report and record any deviations from company procedures or other discrepancies that may affect or indicate a problem with product quality. Determine and implement any immediate corrective action as necessary and ensure the development and implementation of long-term corrective actions by identifying root cause and facilitating the final implementation of the corrective actions
  • Coordinate with other departments and contractors for validation activities

  • Support initiation, actions, and closure of Change Requests and CAPAs, as required
  • Manage equipment maintenance program. Manage routine calibration, validation documentation and monitoring systems.

  • Responsible for managing vendor on site qualification services.
  • Performs all other related duties as assigned

Minimum Requirements:

Technical Knowledge/ Experience:
  • University degree in Engineering or Science
  • Knowledge and understanding of chemistry, engineering, pharmaceutical processes and concepts
  • Knowledge and understanding of cGMPs and bio-pharmaceutical industry guidelines

  • Knowledge and understand of 21 CFR Part 11 and associated computer validation standards
  • Must have good organisational, presentation and technical writing skills

  • Must be confident to work independently with minimal guidance
  • Must have strong analytical and problem-solving skills
  • Must be able to work well with cross functioning teams

Preferred Qualifications / Experience

  • 3 or more years of direct validation experience or Process/Product Engineering Compliance related experience in bio-pharmaceutical environment, experience with 21 CFR Part 11 and cGMP regulations
  • Experience in one or more of the following areas is desired: equipment qualification, temperature mapping, process validation, cleaning validation, sterilization
  • Aseptic manufacturing knowledge

Additional Requirements
  • Job requires occasional extended shift work
  • Willingness to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

  • Keen attention to detail and adherence to Standard Operating Procedures
  • Ability to lift 50lb
  • Must be flexible with changing priorities
Monday-Friday, 8:30 a.m.-5 p.m., with overtime as needed W2 ONLY - NO C2C (corp to corp) - 100% ONSITE (NO REMOTE OR HYBRID) in North Brunswick NJ

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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