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CSV Validation Engineer (cGMP – Building Management System) JD818675

JD818675

DPS Engineering is looking for a capable Computer Systems Validation Engineer to work with a pharmaceutical client in the Boston, MA area. This individual will be responsible for supporting a CSV team with validation activities and deliverables related to Building Management System (BMS) upgrade.

Category:
Engineer Validation & Commissioning
Location:
Massachusetts
Years of Experience Req.:
7+
Date Posted:
01/01/2019
Days Remaining:
39
Employment Type:
Full-time
Education Level Req.:
Bachelors

CSV Validation Engineer (cGMP – Building Management System)      JD818675

Boston, MA area

 

DPS Engineering is looking for a capable Computer Systems Validation Engineer to work with a pharmaceutical client in the Boston, MA area.

 

This individual will be responsible for supporting a CSV team with validation activities and deliverables related to Building Management System (BMS) upgrade.

 

Responsibilities:

  • Responsible for executing and reviewing control systems validation activities including projects associated with PCS, BMS, CMS, OSI PI, and other automation upgrades.
  • Duties include writing and executing validation documents, reviewing and analyz763711.047121ing data, adhering to domestic and international GMP regulations, incorporating continuous improvements into validation activities and policies, and participating in regulatory inspections.
  • Provide technical assessments on change controls, deviations, and investigations.
  • Write, execute, summariz763711.047121e validation activities for Computer Systems and Plant Automation.
  • Develop and assess the following Quality System elements for Validation: CAPAs, Change Controls, Deviations, and GMP Investigations.
  • Participate and contribute in design, development, validation strategy, and routine GMP activities.  
  • Provide technical input to strategy/philosophy for validation activities.
  • Represent validation during site GMP activities and participate on cross-functional teams.

 

Education and Qualifications:

  • Bachelor’s Degree in Computer Science, IT, Engineering or related field.
  • Minimum 5+ years of experience working in a GMP regulated environment with exhibited knowledge and proficiency of Computers Systems Validation and Quality Systems.
  • Experience with authoring validation protocols and reports are strongly desired. 
  • Understanding GMP regulations, quality systems, and ICH guidelines are preferred. 
  • Experience with Valgenesis and TrackWise is a plus.
  • Experience in executing and reviewing control system validation studies.
  • Participation in complex validation projects and cross-functional teams.
  • Knowledge of global cGMP requirements and expectations as they pertain to validation. 
  • Willingness to receive and listen to feedback.
  • Ability to work in a fast-paced environment and ability to manage multiple projects and priorities.
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