Senior Process Engineer

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