CIP Systems Engineer | CQV, Validation & Automation

ENVIRODYNAMICS SOLUTIONS PTE. LTD.

Singapore

On-site

SGD 80,000 - 120,000

Full time

14 days+

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Job summary

EnviroDynamics Solutions Pte Ltd is seeking a CIP Engineer to lead engineering, commissioning, qualification, validation and lifecycle management of CIP systems for pharma/biopharma manufacturing. The role covers concept through CPV, OQ/PQ, CQV documentation and regulatory compliance.

The candidate will review designs, perform hydraulic evaluations, support FAT/SAT, and coordinate CQV activities while driving process optimization and cost reduction across CIP cycles.

Qualifications

  • Bachelor’s degree in Chemical, Mechanical, Bioprocess, Process, Pharmaceutical Engineering or related discipline.
  • 5–10 years of engineering and CQV experience within the pharmaceutical or biopharmaceutical industry.
  • At least three years of direct CIP engineering and qualification experience.
  • Experience in GMP-regulated environments, including: biologics, vaccines, sterile manufacturing, oral solid dosage, active pharmaceutical ingredients.
  • Demonstrated experience preparing and executing CQV protocols and validation documentation.

Responsibilities

  • Review CIP system designs, P&IDs, process flow diagrams, equipment layouts and automation sequences.
  • Assess system cleanability, product-contact surfaces and alignment with process and regulatory requirements.
  • Perform engineering assessments for CIP skids, process vessels, tanks, bioreactors, fermenters, transfer lines, manifolds and fill-finish equipment.
  • Review WFI and purified-water interfaces.
  • Conduct hydraulic and process evaluations to confirm adequate flow, velocity, turbulence and cleaning coverage.
  • Support vendor FAT and SAT activities.
  • Troubleshoot CIP failures and cleaning-effectiveness issues.
  • Optimise CIP cycles to reduce water and chemical consumption, cycle time and operating costs.
  • Develop and execute CQV activities including IQ, OQ, PQ, validation protocols and reports.
  • Coordinate punch-list resolution and ensure timely closure of CQV documentation.
  • Coordinate swab and rinse sampling activities.
  • Collaborate with Manufacturing, Quality Assurance, Quality Control and Validation teams during execution.

Skills

CIP system design
CQV protocols
GMP compliance
P&ID review
Process validation

Education

Bachelor’s degree in Chemical Engineering

Job description

EnviroDynamics Solutions Pte Ltd is seeking a CIP Engineer to lead engineering, commissioning, qualification, validation and lifecycle management of CIP systems for pharma/biopharma manufacturing. The role covers concept through CPV, OQ/PQ, CQV documentation and regulatory compliance.

The candidate will review designs, perform hydraulic evaluations, support FAT/SAT, and coordinate CQV activities while driving process optimization and cost reduction across CIP cycles.

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