CQV Engineer

6 days ago


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

Responsibilities:
  • Develop and execute Commissioning, Qualification, and Validation (CQV) protocols (IQ/OQ/PQ) for pharmaceutical manufacturing facilities, equipment, and systems.
  • Collaborate with project teams to ensure compliance with regulatory standards (e.g., FDA, EMA, GMP).
  • Perform risk assessments, gap analysis, and prepare validation documentation.
  • Support the design and implementation of validation strategies for process and utility systems (e.g., HVAC, water systems, cleanrooms).
  • Lead or participate in FAT, SAT, and related commissioning activities.
  • Ensure all CQV activities meet project timelines and budget requirements.
  • Provide technical expertise during audits and regulatory inspections.
  • Continuously monitor and improve validation processes in alignment with industry standards and innovations.
Requirements:
  • Bachelor’s degree in Engineering, Life Sciences, or a related field.
  • 3-5 years of CQV experience in the pharmaceutical or biotechnology industry.
  • Strong knowledge of GMP, FDA, and other regulatory requirements.
  • Hands-on experience with CQV of manufacturing equipment, including bioreactors, lyophilizers, or packaging lines.
  • Familiarity with computerized systems validation (CSV) is a plus.
  • Excellent analytical, communication, and project management skills.
  • Ability to work effectively in cross-functional teams.
Preferred Skills:
  • Experience with qualification and validation of single-use systems.
  • Familiarity with automation systems such as DeltaV or other DCS platforms.

Tell employers what skills you have

Management Skills
DCS
FDA
GMP
HVAC
Biotechnology
Compliance
Project Management
Packaging
Audits
Water Systems
Regulatory Requirements
Life Sciences
Manufacturing
Commissioning
Utility Systems

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