全职 CIP Engineer 工作, 薪水, Leap29 公司招聘中 - Ricebowl

CIP Engineer (Clean-in-Place) - Engineering & CQV

Location: Singapore

Position: Contract

Duration: 12 Months

Position Overview

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).

Key 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

Commissioning, Qualification & Validation (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 and 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 & Requirements

Bachelor's Degree in one of the following:

• 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

The CIP Engineer will be considered successful when:

• CIP systems are delivered, commissioned, and qualified on schedule
• Cleaning validation programs pass regulatory and internal quality audits
• CQV documentation is completed error-free and on time
• CIP cycle performance meets defined operational and process requirements