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Senior Validation Engineer (cGMP – Pharmaceutical) JD818751

JD818751

DPS is seeking an established and knowledgeable Senior CQV Engineer to work with a BioPharma client in the Boston, MA area. Ideal candidates should have previous experience supporting capital projects, tech transfers, and ongoing validation maintenance.

Category:
Validation
Location:
Massachusetts
Years of Experience Req.:
5+
Date Posted:
15/02/2019
Days Remaining:
6
Employment Type:
Full-time
Education Level Req.:
Bachelors

Senior Validation Engineer (cGMP – Pharmaceutical)       JD818751

Boston, MA area

 

DPS is seeking an established and knowledgeable Senior CQV Engineer to work with a BioPharma client in the Boston, MA area. Ideal candidates should have previous experience supporting capital projects, tech transfers, and ongoing validation maintenance.

 

Responsibilities:

  • Ensure the validated status of site facilities, utilities, equipment and processes is established and maintained in accordance with internal procedures, regulatory requirements and industry guidance/standards.
  • Define and execute the validation strategy associated with site projects covering a range of facilities, utilities, equipment and processes in accordance with project timelines and customer expectations.
  • Maintain an awareness of regulatory and industry best practice trends, hot topics and changes in relation to validation. This includes changes to corporate quality guidance and standards.
  • Present validation packages during regulatory/internal/customer audits. Participate in the response to regulatory audit observations (as required).
  • Drive a risk based validation lifecycle utilising quality risk management principles and tools i.e. FMEA, HAZOP, etc. to ensure that risks are appropriately identified and documented.
  • Provide expertise for the investigation and compliant resolution of non-conformances encountered during (re)qualification/(re)validation activities and site unplanned events.

 

Qualifications & Experience:

  • Bachelor’s Degree in Engineering, Science or related technical field.
  • Minimum of 5+ years in CQV experience in cGMP manufacturing environments.
  • Extensive knowledge of quality systems and performing validation impact assessments.
  • Strong understanding of validation principles including but not limited to FEU, cleaning, process, computer systems and shipping.
  • Excellent technical documentation generation and review skills ensuring the content is technically sound, adheres to applicable site procedures and is suitable for regulatory submission/inspection.
  • Able to work effectively as a part of a cross functional team and maintain good relationships with internal and external stakeholders.
  • Strong interpersonal and communication skills.
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