Senior Validation Engineer

1 week ago

Singapore ANTER CONSULTING PTE. LTD. Full time
Roles & Responsibilities

We are seeking a skilled CQV Engineer to support commissioning, qualification, and validation activities for a pharmaceutical company in Singapore. The ideal candidate will have experience in CQV processes for equipment, facilities, and utilities within a regulated environment. This role requires strong technical expertise, regulatory knowledge, and hands-on experience in executing CQV protocols.

Key Responsibilities:

  • Develop, review, and execute commissioning, qualification, and validation (CQV) protocols (IQ, OQ, PQ) for pharmaceutical equipment, facilities, and utilities.
  • Ensure compliance with regulatory requirements, including FDA, EMA, and cGMP guidelines.
  • Perform risk assessments, impact assessments, and gap analysis for new and existing systems.
  • Coordinate with cross-functional teams, including Engineering, Quality Assurance, Manufacturing, and Validation, to ensure timely execution of CQV activities.
  • Support deviation management, change control, and CAPA implementation related to CQV activities.
  • Conduct system testing, troubleshooting, and data analysis to ensure validation success.
  • Prepare and maintain comprehensive CQV documentation, including reports and summary documents.
  • Assist in audits and inspections by regulatory authorities and internal quality teams.

Requirements:

  • Bachelor's degree in Engineering (Mechanical, Chemical, Electrical, or related field) or Life Sciences.
  • Minimum of 5 years of experience in CQV roles within the pharmaceutical or biotech industry.
  • Strong knowledge of cGMP, FDA, EMA, and other relevant regulatory guidelines.
  • Experience with qualification of process equipment, clean utilities, HVAC, and laboratory instruments.
  • Proficiency in developing and executing CQV protocols (IQ, OQ, PQ).
  • Excellent documentation and technical writing skills.
  • Strong problem-solving and analytical skills.
  • Ability to work in a team-oriented environment and manage multiple priorities.
Tell employers what skills you have

CAPA
FDA
Data Analysis
Technical Writing
GMP
System Testing
HVAC
Teamoriented
Audits
Change Control
Regulatory Requirements
Life Sciences
Laboratory
Manufacturing
Writing Skills
Commissioning

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