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Computer Systems Validation Engineer (cGMP - CSV – DeltaV) JD817600

JD817600

DPS is looking for a knowledgeable DeltaV Validation Engineer to work with a BioPharma client in the Boston, MA area. This individual will be responsible for developing and executing validation protocols for a DeltaV project and executing validation activities in the field. Ideal candidates should have a strong understanding of GMPs and experience providing engineering support in highly regulated or pharmaceutical/biotech facilities.

Category:
Engineer Validation & Commissioning
Location:
Massachusetts
Years of Experience Req.:
3+
Date Posted:
15/06/2020
Days Remaining:
30
Employment Type:
Full-time
Education Level Req.:
Bachelors Preferred

Computer Systems Validation Engineer (CSV – DeltaV)          JD817600

Boston, MA

 

Summary:

 

DPS is looking for a knowledgeable DeltaV Validation Engineer to work with a BioPharma client in the Boston, MA area. This individual will be responsible for developing and executing validation protocols for a DeltaV project and executing validation activities in the field. Ideal candidates should have a strong understanding of GMPs and experience providing engineering support in highly regulated or pharmaceutical/biotech facilities.

 

Core Responsibilities:

  • Expertise in developing the validation protocols and summary reports.
  • Must be able to draft summary reports for approval.
  • Development of CSV and equipment specifications and executing Computer System Validation, System Development Life Cycle (SDLC) and other pharmaceutical equipment/system commissioning/validation (IQ/OQ/PQ) protocols in accordance with Good Engineering Practices, GAMP, local SOPs, industry best practices and other industry related guidance documents.
  • Assess the impact of changes to cGMP equipment/systems and methods and establish the applicable Validation Plan to ensure the validated status following changes.
  • Experience in technical writing, report generation of testing methodologies of automated systems.

 

Qualifications:

  • Bachelor’s Degree in Computer Science or Engineering discipline.
  • 3+ years of demonstrated experience in cGMP automation/computeriz248568.505874ed systems, quality and compliance areas in the pharmaceutical industry.
  • Thorough understanding of industry standards and best practices for computer system validation.
  • Must have demonstrated knowledge of DeltaV systems.
  • Position requires a broad range of experience with validation of equipment.
  • Ability to interact with internal and external customers in a professional and helpful manner.
  • Excellent verbal and written communications skills, ability to explain system issues clearly and concisely.
  • Must be able to work independently and as part of a team to deliver solutions on time and according to schedule.
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