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Senior Validation Engineer (cGMP – Pharmaceutical) JD818629

JD818629

DPS is seeking an established and knowledgeable Senior CQV Engineer to work with a BioPharma client in the NH area. Ideal candidates should have previous experience supporting capital projects, tech transfers, and ongoing validation maintenance. This individual will be primarily responsible for the design, authorship, and execution of qualification studies and protocols for utilities, automated systems, and other new/modified pieces of equipment.

Category:
Engineer Validation & Commissioning
Location:
New Hampshire
Years of Experience Req.:
5+
Date Posted:
01/10/2019
Days Remaining:
40
Employment Type:
Full-time
Education Level Req.:
Bachelors

Senior Validation Engineer (cGMP – Pharmaceutical)       JD818629

NH area

 

DPS is seeking an established and knowledgeable Senior CQV Engineer to work with a BioPharma client in the NH area. Ideal candidates should have previous experience supporting capital projects, tech transfers, and ongoing validation maintenance. This individual will be primarily responsible for the design, authorship, and execution of qualification studies and protocols for utilities, automated systems, and other new/modified pieces of equipment.

 

Responsibilities:

  • Design, author, and execute protocols in support of capital and tech transfer projects.
  • Responsible for the commissioning and qualification of biotechnology-based manufacturing systems.
  • Support engineering lifecycle documentation reviews/approval to allow commencement of CQV protocol generation activities.
  • Author and execute commissioning lifecycle documentation for project equipment.
  • Support and coordinate discrepancy resolution and close out.
  • Provide technical support to change controls, deviations, and CAPAs.

 

Qualifications & Experience:

  • Bachelor’s Degree in Science or related technical field.Minimum of 5+ years of CQV experience in the biotechnology or pharmaceutical industries.
  • Experience with automation systems like Honeywell, DeltaV, and PLC based systems is required.
  • Must have demonstrated understanding of cGMP.
  • Strong experience with capital projects is necessary.
  • Proven ability to manage projects while meeting all deliverables and timelines.
  • Excellent written and verbal communication skills
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