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.)