Senior Process Engineer (Pharma) (SG)
Date Posted: April 4, 2025
Job Description
We are seeking an experienced and driven Senior Process Engineer to join our pharmaceutical manufacturing team in Singapore. This role plays a key part in driving process optimisation, ensuring GMP compliance, and supporting new product introductions within a regulated environment.
Key Responsibilities
Lead and support process design, optimisation, scale-up, and tech transfer activities.
Collaborate with cross-functional teams to implement continuous improvement and cost-reduction initiatives.
Troubleshoot process deviations and drive root cause investigations using risk-based approaches.
Develop and revise process documentation, including SOPs, batch records, and validation protocols.
Support equipment qualification and process validation in compliance with cGMP and regulatory standards.
Provide technical expertise during audits, regulatory inspections, and internal reviews.
Monitor and analyse process trends to ensure performance, yield, and quality targets are met.
Mentor junior engineers and provide technical leadership on key projects.
Liaise with R&D, QA, QC, Maintenance, and Manufacturing teams to ensure seamless operations.
Ensure health, safety, and environmental (HSE) compliance in all engineering activities.
Required Qualifications and Skills
Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Engineering, or related field.
Minimum 5–8 years of process engineering experience in pharmaceutical or biopharmaceutical manufacturing.
Strong knowledge of GMP, ICH, FDA and PIC/S guidelines.
Experience with tech transfer, process validation, and statistical analysis (e.g., DOE, SPC).
Proficient in troubleshooting, problem-solving, and risk assessment methodologies.
Excellent communication and cross-functional collaboration skills.
Prior experience with sterile/aseptic manufacturing, biologics, or oral solid dosage (OSD) is a plus.
If you are keen to grow your career with this job, apply with us and send us your resume now. All shortlisted candidates will be contacted shortly.
Reference no.: 122-4948-2918-NW
Registration no.: 968446516E