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CQV Engineer


  • Develop, review and/or approve validation lifecycle documents and protocols/reports and deliverables in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion. 

  • Take lead and review project design documents (P&IDs, PFDs, URS etc.) 

  • Define user requirements and create SOPs or documentation related to the validation activities 

  • Manage qualification execution and lead validation deviation investigation encountered in qualification.

  • Create and review validation lifecycle documents: User Requirement Specification, Functional Specification, Risk Assessments, Validation Protocols (IQ/OQ/PQ/CPV) and Reports, Study Protocols and Reports, Requirement Traceability Matrix, CFR Part 11 assessment and validation submission dossier

  • Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification activities

  • Participate in site Validation Maintenance Program.

  • Write execution related deviations and change requests

  • Support change implementation on site.

  • Manage Change Control to update SOPs, Risk Assessment, Requirement Traceability Matrix and/or Automation System Life cycle documentation as needed

  • Perform validation documentation and/ or support validation documentation in accordance to the division procedures

  • Regular preview of pending activities to maintain validation status with validation lead, supervisor or manager

  • Ensure validation execution meets compliance, validation standards and cGMP requirements 

  • Any other task as assigned by Supervisor/Manager

About You:

  • Diploma/Degree in Engineering or Science Disciplines with 3 to 5 years experience in Pharmaceutical Industry 

  • Proven track record in Equipment Qualification for HVAC and Utilities Validation (IQ/OQ/PQ/CPV)

  • In-depth knowledge on cGMP, GDP and ASTM E2500

  • Proactive and self-motivated

  • Demonstrated proficiency of written and verbal communication skills in English (including technical writing and presentations)  

  • Effective Project Management, leadership, communication and interpersonal skills 

Submit your resume to
Only shortlisted candidates will be contacted. 
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