Validation Engineer

Job#: 1279285

Job Description:

Apex Systems is seeking a Validation Engineer to join our client, a global leader in the pharmaceutical industry. This role will site onsite in Bloomington, IN. It is starting as a 3 month contract, with potential to get extended further.

Requirements:

  • Min 10-15 years direct experience in validation/qualification of equipment used in the aseptic operations
  • Proven Technical writing capabilities
  • Ability to independently prepare a regulatory package on the IQ/OQ and PQ of process or equipment with little guidance
  • Ability to execute and troubleshoot and provide direction and remediation solutions during execution issues
  • Min 10-15 years in GMP compliance roles with significant experience in the area of operations and operations process excellence
  • In depth understand of the GMP regulations and how to apply them – Proven skills around operational excellence with knowledge in
  • Skilled in problem solving and the use of standard tools for process optimization  - LEAN sigma trained greenbelt preferred
  • Proven experience in deviation management with excellent oral and written skills
  • Critical thinker who drives options on design based on data analysis

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EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystems.com or 844-463-6178.

Employee Type:
Contract

Location:
Bloomington, IN, US

Job Type:
Engineering and Technicians

Date Posted:
August 11, 2022