Senior Process Engineer

Brunel; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

Brunel Singapore is seeking an experienced Senior Process Engineer with pharmaceutical manufacturing background to support design, delivery and qualification of process equipment for GMP facilities.

You will coordinate design activities, liaise with suppliers, review C&Q docs, and ensure compliance with cGMP, ISPE and ASME BPE standards while maintaining timelines.

Qualifications

• Bachelor's degree required in Chemical/Process Engineering.
• 6+ years of process engineering experience in pharma/biotech life sciences.
• Solid knowledge of C&Q practices and validation lifecycle (IQ/OQ/PQ).
• Familiarity with cGMP and ISPE/ASME BPE standards is desirable.

Responsibilities

• Coordinate process design activities with the design consultant and stakeholders.
• Manage interfaces between the user team and equipment suppliers for qualification.
• Review C&Q documentation to ensure GMP and regulatory alignment.
• Coordinate with construction to confirm equipment readiness and installation sequencing.
• Participate in Process Hazard Analysis (PHA) workshops.
• Prepare site-specific engineering docs: scopes, specs, standards.
• Provide progress updates to Site Engineering Lead.
• Support troubleshooting during design, installation and qualification.
• Ensure deliverables meet cGMP and ISPE/BPE standards.

Skills

Process engineering

C&Q practices

Regulatory compliance

Project coordination

Education

Bachelor's degree in Chemical Engineering

Job description

Our client is a global professional services firm delivering engineering, design, planning, project management, and consulting services across the built environment. We are seeking an experienced Senior Process Engineer with a pharmaceutical manufacturing background to support the design, delivery, and qualification of process equipment for a GMP-regulated facility.

Key Responsibilities

• Coordinate process design activities with the design consultant and key project stakeholders, ensuring alignment with pharmaceutical facility requirements, GMP standards, and project timelines.
• Manage process equipment package interfaces between the client user team and equipment suppliers, resolving technical queries and ensuring scope and compliance alignment.
• Review commissioning and qualification (C&Q) documentation for process equipment packages, ensuring alignment with GMP, validation lifecycle, and regulatory expectations (e.g. FDA, EMA, or local health authority requirements as applicable).
• Liaise closely with the construction team to confirm equipment readiness, coordinate installation sequencing, and resolve on-site installation constraints without compromising qualification timelines.
• Facilitate and actively participate in Process Hazard Analysis (PHA) workshops, contributing engineering input to identify and mitigate process, safety, and product-quality risks.
• Develop site-specific engineering documentation, including scopes of work, technical specifications, engineering standards, and variance management records, in accordance with pharmaceutical industry norms.
• Provide regular progress updates, technical input, and engineering support to the Site Engineering Lead to support project reporting and decision-making.
• Support troubleshooting and resolution of process equipment issues throughout design, installation, and qualification phases of pharmaceutical manufacturing systems (e.g. bioreactors, purification skids, WFI/clean utilities, CIP/SIP systems, as relevant to facility type).
• Ensure process engineering deliverables comply with applicable cGMP requirements, industry codes (e.g. ISPE baseline guides, ASME BPE), and client/company specifications.

Qualifications & Experience

• Bachelor's degree in Chemical Engineering, Process Engineering, or a related engineering discipline.
• 6+ years of process engineering experience within the pharmaceutical, biotech, or broader life sciences manufacturing sector.
• Strong working knowledge of commissioning and qualification (C&Q) practices, documentation, and validation lifecycle (IQ/OQ/PQ).
• Solid understanding of cGMP requirements and regulatory expectations for pharmaceutical manufacturing facilities.
• Familiarity with pharmaceutical process systems such as clean utilities, bioprocessing/API equipment, or sterile manufacturing systems is an advantage.

Candidates must be based in Singapore.

(Brunel International South East Asia Pte Ltd, Registration Number: 199603098R | Company License Number : 16S8067 | Eve Ng EAP Registration Number R2198025.)