Senior Process Engineer (Pharmaceutical)

Amaris Consulting Pte Ltd; Singapore; On-site; SGD 90,000 - 140,000; Full time

Job summary

Amaris Consulting Pte Ltd in Singapore is seeking a Life Sciences Process Engineer to provide process engineering support within a pharma/biopharma 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.

You will develop P&IDs, URS, risk assessments, design reviews, FAT/SAT/IQ/OQ/PQ activities, and lead change controls, deviations and

Qualifications

• Bachelor's degree in Chemical Engineering, Process Engineering, Pharmaceutical Engineering, Biotechnology, Mechanical Engineering, or related field.
• 5–8 years of experience in process engineering within pharmaceutical/biopharmaceutical/manufacturing environments.
• Experience with process design, P&ID development, URS, risk assessments, and HAZOP.
• Understanding of qualification/validation activities including FAT, SAT, IQ, OQ, PQ and requalification.
• Practical knowledge of CIP, SIP, washers, autoclaves or similar process systems.
• Experience managing change controls, deviations, investigations and CAPAs.
• Familiar with automated manufacturing processes including equipment modules, recipes, and parameters.
• Ability to collaborate with MS&T, Automation, Manufacturing, Quality, Validation and Engineering teams.

Responsibilities

• Develop process designs, P&IDs, URS, SRA, FRA and related documentation.
• Participate in design reviews, design qualification activities and HAZOP studies.
• Generate, review and maintain process engineering documents throughout their 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, reliable site operations.
• Lead improvements focused on equipment performance, yield and cycle-time reduction.
• Collaborate with MS&T, Automation, Manufacturing, Quality, Validation and Engineering teams.
• Translate process requirements into automation 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 according to operational needs.
• Support lead responsibilities during absences and delegated meetings.
• Offer guidance to assigned resources as needed.
• Support continuous improvement initiatives and other duties.

Skills

Process design

P&ID development

URS

Risk assessments

HAZOP

Qualification & Validation

FAT/SAT/IQ/OQ/PQ

CIP/SIP

CAPAs & Change control

Automation exposure

Troubleshooting

Cross-functional collaboration

Education

Degree in Chemical Engineering or related field

5–8 years process engineering experience in pharma/biopharma

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