CQV Engineer (CIP System)

Position Overview

The CIP Engineer is responsible for the engineering, commissioning, qualification, validation and lifecycle management of Clean-in-Place (CIP) systems within pharmaceutical and biopharmaceutical manufacturing facilities.

The role supports projects from concept design through Operational Qualification (OQ), Performance Qualification (PQ) and Continued Process Verification (CPV), ensuring compliance with cGMP, FDA, EU GMP Annex 1,ISPE and company quality standards.

Key Responsibilities

CIP Engineering

• 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 package reviews, Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
• Troubleshoot CIP failures and cleaning-effectiveness issues.
• Optimise CIP cycles to reduce water and chemical consumption, cycle time and operating costs.

Commissioning, Qualification and Validation

• Develop and execute commissioning and qualification activities for CIP systems.
• Prepare and execute:
• Commissioning Test Plans
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Validation protocols and summary reports
• Develop and maintain requirements traceability matrices.
• Coordinate punch-list resolution and ensure timely closure of CQV documentation.

Cleaning Validation

• Support the development of cleaning-validation strategies.
• Define worst-case products and cleaning-validation matrices.
• Coordinate swab and rinse sampling activities.
• Analyse validation data and prepare supporting reports.
• Collaborate with Manufacturing, Quality Assurance, Quality Control and Validation teams during execution.

Automation and Controls

• Review CIP automation logic, control strategies and sequence of operations.
• Verify that automation functions meet process, safety and GMP requirements.

Qualifications and Experience

• Bachelor’s degree in Chemical, Mechanical, Bioprocess, Process, Pharmaceutical Engineering or a 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 one or more GMP-regulated environments, including:
• Biologics
• Vaccines
• Sterile manufacturing
• Oral solid dosage
• Active pharmaceutical ingredients
• Demonstrated experience preparing and executing CQV protocols and validation documentation.

Technical Competencies

• CIP system design and operation
• Cleaning-validation principles
• Commissioning and qualification
• GMP and regulatory requirements
• P&ID and process-document review
• FAT and SAT execution
• Technical documentation and report writing
• Risk assessment and troubleshooting

Key Attributes

• Strong technical and problem-solving capabilities
• Effective project execution and stakeholder management
• Excellent attention to detail and documentation discipline
• Strong cross-functional communication skills
• Continuous-improvement and risk-based mindset

Interested candidates kindly click the APPLY NOW button.

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EnviroDynamics Solutions Pte Ltd

EA License No.: 12C6285