Senior Process Engineer (Pharma)

BRUNEL INTERNATIONAL SOUTH EAST ASIA PTE. LTD.; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

Brunel International South East Asia Pte Ltd is seeking an experienced Senior Process Engineer with a pharmaceutical manufacturing background to design, deliver, and qualify process equipment for a GMP-regulated facility.

You will coordinate process design activities, manage interfaces with equipment suppliers, and review C&Q documentation to ensure GMP compliance across IQ/OQ/PQ. Strong knowledge of cGMP and ISPE/BPE standards is essential.

Qualifications

• Bachelor's degree in Chemical Engineering, Process Engineering, or a related engineering discipline.
• 6+ years of process engineering experience within pharmaceutical, biotech, or life sciences manufacturing.
• Strong knowledge of commissioning and qualification practices and validation lifecycle.
• Solid understanding of cGMP requirements and regulatory expectations.
• Familiarity with clean utilities, bioprocessing/API equipment, or sterile systems is an advantage.

Responsibilities

• Coordinate process design activities with the design consultant and key project stakeholders to meet GMP and project timelines.
• Manage process equipment package interfaces between client user team and equipment suppliers.
• Review C&Q documentation for process equipment packages to align with GMP and regulatory expectations.
• Liaise with construction team to confirm equipment readiness and coordinate installation sequencing.
• Facilitate Process Hazard Analysis (PHA) workshops and identify risks.
• Develop site-specific engineering documentation including scopes of work, specs, and standards.
• Provide progress updates and engineering support to the Site Engineering Lead.
• Support troubleshooting of process equipment issues during design, installation, and qualification.
• Ensure deliverables comply with cGMP and industry codes (ISPE, ASME BPE).

Skills

Process design

GMP compliance

C&Q (IQ/OQ/PQ)

Regulatory compliance

Project coordination

Education

Bachelor's degree in Chemical Engineering or Process 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.)