Senior Process Engineer - Pharma & Biopharma Systems Lead

AMARIS ACT PTE. LTD.

Singapore

On-site

SGD 90,000 - 130,000

Full time

7 days ago

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Job summary

AMARIS ACT PTE. LTD. in Singapore seeks a Process Engineer to support pharmaceutical/biopharmaceutical manufacturing.

You will develop process designs, URS, and risk assessments, contribute to design reviews and qualification activities, and drive continuous improvement for safe, reliable site operations. You will lead change controls, CAPAs, and qualification activities, manage CIP/SIP systems, and collaborate with MS&T, Automation, Manufacturing, Quality, Validation, and Engineering teams to

Qualifications

Degree in Chemical Engineering, Process Engineering, Pharmaceutical Engineering, Biotechnology, Mechanical Engineering, or a related field.
5–8 years of experience in process engineering within pharma/biopharma or similarly regulated manufacturing.
Experience with process design, P&ID development, URS, risk assessments, design reviews, and HAZOP.
Experience with qualification and validation activities, including FAT, SAT, IQ, OQ, PQ, and requalification.
Knowledge of CIP, SIP, washers, autoclaves, or similar pharma process systems.
Experience managing change controls, deviations, investigations, and CAPAs.
Understanding automated manufacturing processes, equipment modules, recipes, and process parameters.
Ability to collaborate with MS&T, Automation, Manufacturing, Quality, Validation, and Engineering teams.

Responsibilities

Develop process designs, P&IDs, URS, SRA/FRA, and other engineering documents.
Participate in design reviews, design qualification activities, and HAZOP studies.
Generate and maintain process engineering documentation throughout its lifecycle.
Support FAT, SAT, IQ, OQ, PQ, qualification and requalification activities.
Lead process engineering change controls, deviations, and CAPAs.
Own process systems and equipment, including SIP, CIP, washers, and autoclaves.
Provide independent technical support to ensure safe and reliable site operations.
Lead improvements focused on equipment performance, yield, and cycle-time reduction.
Act as liaison between MS&T and Automation teams; translate requirements into modules, recipes, and parameters.
Support recipe testing and system changes with Automation teams.
Lead troubleshooting, design reviews, and optimization to minimize risks.
Provide on-call support for complex process issues as needed.
Support lead responsibilities during absences and represent the function in meetings.
Provide guidance to assigned resources when required.
Support continuous improvement initiatives and other duties as assigned.