Senior Process Engineer

Amaris Australiancapitalterritory; Singapore; On-site; SGD 90,000 - 120,000; Full time

Job summary

Amaris Australiancapitalterritory Life Sciences team seeks a process engineer to provide process engineering support in pharmaceutical or biopharmaceutical manufacturing. You will contribute to equipment and process design, qualification, troubleshooting, automation changes, and continuous improvement while helping ensure safe and reliable site operations.

You will develop process designs, P&IDs, URS, SRA, FRA, and other engineering documentation; participate in design reviews, qualification

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 a pharmaceutical, biopharmaceutical, biotechnology, or similarly regulated manufacturing environment.
• Experience with process design, P&ID development, URS, risk assessments, design reviews, and HAZOP.
• Understanding qualification and validation activities, including FAT, SAT, IQ, OQ, PQ, and requalification.
• Knowledge of CIP, SIP, washers, autoclaves, or comparable pharmaceutical process systems.
• Experience in managing change controls, deviations, investigations, and CAPAs.
• Understanding automated manufacturing processes, including equipment modules, recipes, and process parameters.
• Ability to collaborate with MS&T, Automation, Manufacturing, Quality, Validation, and Engineering teams.
• Strong troubleshooting, analytical, documentation, and problem-solving skills.
• Ability to work independently, propose practical solutions, and assume lead responsibilities when required.
• Availability for on-call technical support according to operational needs.

Responsibilities

• Develop process designs, P&IDs, URS, SRA, FRA, and other engineering documentation.
• Participate in design reviews, design qualification activities, and HAZOP studies.
• Generate, review, and maintain process engineering documentation throughout its lifecycle.
• Support FAT, SAT, IQ, OQ, PQ, qualification, requalification, and validation activities.
• Lead and manage process engineering change controls, deviations, and CAPAs.
• Take ownership of process systems and equipment (SIP, CIP, washers, autoclaves).
• Provide independent technical support to ensure safe, reliable site operations.
• Lead improvements focused on equipment performance, yield, and cycle-time reduction.
• Act as link between MS&T and Automation teams; translate requirements into automation modules, recipes, and parameters.
• Support recipe testing and collaboration with Automation teams to implement system changes.
• Lead troubleshooting, design reviews, and optimization to minimize risks; provide on-call support as needed.
• Support lead responsibilities during absences and represent the function in meetings.

Skills

Process design

HAZOP

FAT/SAT/IQ/OQ/PQ

Change controls

CAPA

SIP/CIP

Automation collaboration

On-call support

Leadership

Troubleshooting

Education

Bachelor's degree in Chemical Engineering or related field

Job description

Job Description

You’ll have the opportunity to work within our Life Sciences team, providing process engineering support in a pharmaceutical or biopharmaceutical manufacturing environment. You will contribute to equipment and process design, qualification, troubleshooting, automation changes, and continuous improvement while helping ensure safe and reliable site operations.

ABOUT THE JOB

• Develop process designs, P&IDs, User Requirement Specifications (URS), System Risk Assessments (SRA), Functional Risk Assessments (FRA), and other engineering documentation
• Participate in design reviews, design qualification activities, and HAZOP studies
• Generate, review, and maintain process engineering documentation throughout its lifecycle
• Support FAT, SAT, IQ, OQ, PQ, qualification, requalification, and validation activities
• Lead and manage process engineering change controls, deviations, and CAPAs
• Take ownership of process systems and equipment, including SIP, CIP, washers, and autoclaves
• Provide independent technical support to ensure safe, reliable, and efficient site operations
• Lead process and engineering improvements focused on equipment performance, yield optimization, and cycle-time reduction
• Act as the link between Manufacturing Science and Technology (MS&T) and Automation teams
• Translate process requirements into the required automation equipment modules, recipes, and parameters
• Support recipe testing and collaborate with Automation teams to implement system changes
• Lead process and engineering troubleshooting, design reviews, and optimization activities to minimize operational and supply risks
• Provide on-call support for complex process issues according to operational requirements, which may include support outside regular working hours
• Support lead responsibilities during absences and represent the function in delegated meetings
• Provide guidance or limited oversight to assigned resources when required
• Support continuous improvement initiatives and perform other responsibilities assigned by the manager

ABOUT YOU

• Degree in Chemical Engineering, Process Engineering, Pharmaceutical Engineering, Biotechnology, Mechanical Engineering, or a related field
• 5–8 years of experience in process engineering within a pharmaceutical, biopharmaceutical, biotechnology, or similarly regulated manufacturing environment.
• You have experience with process design, P&ID development, URS, risk assessments, design reviews, and HAZOP
• You understand qualification and validation activities, including FAT, SAT, IQ, OQ, PQ, and requalification
• You have practical knowledge of CIP, SIP, washers, autoclaves, or comparable pharmaceutical process systems
• You are experienced in managing change controls, deviations, investigations, and CAPAs
• You understand automated manufacturing processes, including equipment modules, recipes, and process parameters
• You can collaborate effectively with MS&T, Automation, Manufacturing, Quality, Validation, and Engineering teams
• You demonstrate strong troubleshooting, analytical, documentation, and problem-solving skills
• You can work independently, propose practical solutions, and assume lead responsibilities when required
• You are available to provide on-call technical support according to operational needs