Quality Assurance Validation Engineer -Biopharma

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Quality Assurance Validation Engineer -Biopharma

02 Dec 2024
Massachusetts, Cambridge, 02138 Cambridge USA
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Quality Assurance Validation Engineer -Biopharma

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Job Description

  • Generate system impact assessments, equipment risk assessments, user requirement specifications, and other engineering lifecycle documents for various equipment.
  • Develop and execute Facility, Utilities, Systems, and Equipment commissioning and qualification protocols as required.
  • Participate in FAT, SAT, as well as installation/operation of equipment prior to validation.
  • Perform periodic reviews of qualified equipment, and develop and execute requalification protocols, as applicable.
  • Support cleaning validation activities utilized in current and future processes.
  • Support on-going validation projects; interact with all other departments for validation-related issues.
  • Lead small to medium validation projects from inception to completion.

Qualifications

  • Bachelor’s degree in a scientific discipline, engineering, or a related field.
  • 5 years of experience in Validation, Quality Assurance, or a technical support role.
  • Strong communication and technical writing skills. Prior validation experience and authoring validation documents is a must. Experience managing and writing deviations, CAPA, and change control is preferred.
  • Solid understanding of relevant FDA/EMA/ICH validation requirements.
  • Experience with Veeva Vault QMS or similar software is preferred.
  • Strong analytical, organizational, and critical thinking skills.
  • Flexibility to take on other duties as assigned.
  • Ability to work in a fast-paced setting and adjust to a changing environment.

Full benefits package is offered and can be discussed during the interview process.

Additional Information

Full benefits package is offered and can be discussed during the interview process.

This position is a direct placement with our client.

US Work Authorizationrequired

No c/c or 1099

Please attach a WORD resume to your submission

All of your information will be kept confidential according to EEO guidelines.

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