Senior Process Engineer, Life Sciences & Automation

Amaris Consulting Pte Ltd; Singapore; Vor Ort; SGD 90.000 - 140.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

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

Ausbildung

Degree in Chemical Engineering or related field

5–8 years process engineering experience in pharma/biopharma

Jobbeschreibung

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