We use cookies to improve your experience on this website.

Senior Computer Systems Validation (CSV) Engineer (cGMP) JD817728

JD817728

DPS is looking for a proven 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 GxP Computerized Systems. Ideal candidates should have previous experience leading the build of a robust risk based QA CSV program with a focus on GxP impact to Product Quality, Patient Safety and Data Integrity.

Category:
Validation Engineer
Location:
Massachusetts
Years of Experience Req.:
5+
Date Posted:
01/09/2019
Days Remaining:
10
Employment Type:
Full-time
Education Level Req.:
Bachelors

Senior Computer Systems Validation (CSV) Engineer (cGMP)            JD817728

Boston, MA

 

Summary:

DPS Engineering is looking for a proven 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 GxP Computeriz958008.016191ed Systems. Ideal candidates should have previous experience leading the build of a robust risk based QA CSV program with a focus on GxP impact to Product Quality, Patient Safety and Data Integrity.

 

Responsibilities:

  • Support continuous improvement of CSV program including Review of current Site and global SOPs/Guidance Documents and building Site specific CSV Policy, supporting SOPs, Work Instructions/Guidelines, Forms and launch for use.
  • Provide consulting recommendations based on extensive knowledge and application of industry standards; establish validation strategy and create a project plan.
  • Develop a Computer Systems Master Plan to organiz958008.016191e current validation status of existing systems and utiliz958008.016191e this plan to monitor risk/remediation efforts.
  • Perform Gap Analysis, Risk assessments of internal Computeriz958008.016191ed Systems, software suppliers and hosted data centers.
  • Develop procedures related to Laboratory Computeriz958008.016191ed Systems.
  • Support implementation of IT Infrastructure Qualification program.
  • Participate in Validation Deliverables authoring and/or execution.
  • Solve problems during validation process and address/advise on issues such as deficiencies and discrepancies.
  •  

Education and Qualifications:

  • BS Degree in Computer Science, IT, Engineering or related field.
  • Master Degree or ASQ/CISA Certification is preferred.
  • Minimum 10+ years of experience working in a GMP regulated environment with exhibited knowledge and proficiency of Computers Systems Validation and Quality Systems.
  • Proven experience in the development, implementation and lifecycle management of Computeriz958008.016191ed Systems Validation program.
  • Highly proficient with all the phases of SDLC (System Development Life Cycle) process, validation methodologies and concepts of Qualification/Validation principles.
  • Strong ability to develop and/or execute Validation Plans, Reports, Protocols (IQ/OQ/PQ), Data Migration, Traceability Matrix, Risk Assessments for Computeriz958008.016191ed system.
  • Working knowledge of SDLC, GAMP 5, USP 1058 ITIL frameworks is a must.
  • Thorough knowledge of FDA/EU regulations related to CSV, including Annex 11, 21 CFR Part 11, Part 210, Part 211, Part 820 is required.
  • Prior experience validating systems like SAP, LMS, eDMS, QMS, SCM, etc. is a plus.
  • Must have strong technical writing skills.
Back to top