Validation Engineer (CQV) — GMP Pharma Impact & Growth

No-Deviation-Pte.-Ltd

Singapore

On-site

SGD 70,000 - 100,000

Full time

9 days ago
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Benefits offered by this job

Generous Leave
Health & Wellness Coverage
Professional Development
Inclusive Culture
Pharma Impact

Job summary

No deviation is seeking a Validation Engineer to support qualification and validation activities within a GMP pharmaceutical/biopharmaceutical manufacturing environment. The role will be responsible for planning, executing, documenting, and supporting validation activities for equipment, systems, utilities, and manufacturing processes.

Collaborate with Engineering, Manufacturing, QA, QC, MSAT, Automation and vendors to coordinate validation activities and ensure adherence to GMP requirements,

Qualifications

  • Diploma or Degree in Engineering, Pharmaceutical Sciences, Biotechnology, Life Sciences, or related discipline.
  • Experience in validation, qualification, CQV, engineering or pharmaceutical manufacturing.
  • Strong understanding of GMP and equipment qualification principles.
  • Experience with IQ/OQ/PQ protocols preferred.
  • Familiarity with deviation, CAPA, change control and risk assessment processes.
  • Knowledge of regulatory expectations such as EU GMP/FDA requirements would be an advantage.

Responsibilities

  • Develop, review, and execute validation and qualification documentation.
  • Perform qualification and validation activities for equipment, systems, utilities and manufacturing processes.
  • Support commissioning and qualification activities for new equipment and facility projects.
  • Coordinate IQ, OQ and PQ testing in accordance with approved protocols.
  • Review test results, identify discrepancies, and ensure proper documentation and resolution of deviations.
  • Support regulatory inspections and internal/external audits where required.

Skills

GMP knowledge
Validation planning
IQ/OQ/PQ testing
Documentation
Cross-functional collaboration

Education

Diploma or Degree in Engineering/Pharmaceutical Sciences/Life Sciences

Job description

No deviation is seeking a Validation Engineer to support qualification and validation activities within a GMP pharmaceutical/biopharmaceutical manufacturing environment. The role will be responsible for planning, executing, documenting, and supporting validation activities for equipment, systems, utilities, and manufacturing processes.

Collaborate with Engineering, Manufacturing, QA, QC, MSAT, Automation and vendors to coordinate validation activities and ensure adherence to GMP requirements,

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