CIP Engineer

Position: CIP Engineer (Clean-in-Place) - Engineering & CQV Location: Singapore

The CIP Engineer will be responsible for the design review commissioning qualification validation optimization and lifecycle management of Clean-in-Place (CIP) systems within pharmaceutical biopharmaceutical vaccine API and sterile manufacturing facilities. The role requires a combination of engineering expertise and CQV experience to ensure that CIP systems are designed installed tested and operated in compliance with cGMP FDA EU GMP Annex 1 ISPE and company quality standards.

The successful candidate will support project execution from Concept Design through Operational Qualification (OQ) Performance Qualification (PQ) and Continued Process Verification (CPV)

Responsibilities Engineering Responsibilities

Review and support the design of CIP systems for pharmaceutical and biopharmaceutical manufacturing facilities.

Evaluate P&IDs process flow diagrams equipment layouts and automation sequences related to CIP systems.

Verify CIP system design against process requirements product contact surfaces cleanability and regulatory expectations.

Support FAT SAT and vendor package reviews. Conduct engineering assessments for:

CIP skids Process vessels and tanks Bioreactors and fermenters Transfer lines and manifolds Fill-finish equipment WFI and purified water interfaces

Perform hydraulic and process evaluations to ensure adequate flow velocity turbulence and coverage.

Identify opportunities for CIP cycle optimization to reduce water chemical consumption and cycle times.

Support troubleshooting of CIP failures and cleaning effectiveness issues.

CQV Responsibilities

Develop and execute Commissioning and Qualification activities for CIP systems. Prepare and execute:

Commissioning Test Plans (CTPs) Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Validation Protocols Validation Summary Reports (VSRs)

Support traceability matrix development and management. Coordinate punch-list resolution and CQV documentation closure.

Cleaning Validation Responsibilities

Support cleaning validation strategy development. Define worst-case product selection and cleaning validation matrices. Coordinate sampling activities including:

Swab sampling Rinse sampling

Analyze cleaning validation data and support final reports. Collaborate with Manufacturing QA QC and Validation teams during execution.

Automation & Controls Support

Review CIP automation logic and sequence of operations.

Qualifications and other requirements

Education

Bachelor's Degree in: Chemical Engineering Mechanical Engineering Bioprocess Engineering Process Engineering Pharmaceutical Engineering Related Engineering Discipline

Experience

5-10 years of experience in pharmaceutical or biopharmaceutical engineering and CQV.

Minimum 3 years of direct CIP engineering and qualification experience. Experience supporting GMP regulated facilities including:

Biologics Vaccines Sterile Manufacturing OSD API Facilities

Proven experience executing CQV protocols and validation documentation.

Technical Skills

CIP system design and operation Cleaning validation principles Commissioning and Qualification GMP regulations P&ID review FAT/SAT execution Technical report writing

Key Competencies

Technical Leadership Problem Solving Project Execution Cross-Functional Collaboration Risk Assessment Documentation Excellence Communication and Stakeholder Management Attention to Detail Continuous Improvement Mindset

Required Skills:

cip review cip system