Process Engineer

Coalesce Management Consulting; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

Coalesce Management Consulting is seeking a Process Engineer to support manufacturing operations in a leading biopharmaceutical facility. You will work with cross-functional teams to ensure reliable, compliant, and efficient processes while driving continuous improvement initiatives.

The role involves qualification activities for GMP equipment, documentation maintenance, and collaboration with Engineering, Manufacturing, QA, Validation, and Operations to ensure inspection-ready records and

Qualifications

• Bachelor's degree in Engineering or related field (preferred).
• Strong vendor management, process/manufacturing, and equipment lifecycle management experience.
• Good organizational, problem-solving, and communication skills.

Responsibilities

• Support Qualification activities for autoclaves, washers, and related GMP equipment.
• Prepare, execute, review, and maintain validation documentation (protocols, reports, risk assessments, test scripts).
• Collaborate with Engineering, Manufacturing, QA, Validation, and Operations to support qualification and validation.
• Support data analysis from qualification studies and assist with deviation investigations and CAPA implementation.
• Ensure qualification documentation complies with GMP, FDA, EMA, and internal quality requirements.
• Support change controls, deviation investigations, and regulatory inspection readiness related to validated equipment and processes.
• Review operating parameters and qualification requirements to support validation readiness.
• Participate in commissioning, qualification, and validation activities for new or modified equipment.
• Maintain validation lifecycle documentation and ensure records are inspection-ready.
• Assist with continuous improvement initiatives related to equipment qualification, process validation, and compliance activities.

Skills

Vendor management

Process manufacturing

Equipment lifecycle management

Communication skills

Problem-solving

Education

Bachelor's degree in Engineering or related field

Job description

We are seeking a Process Engineer to support manufacturing operations within a leading biopharmaceutical facility. The successful candidate will work closely with cross-functional teams to ensure reliable, compliant, and efficient manufacturing processes while driving continuous improvement initiatives.

Key Responsibilities:

• Support Qualification (IOPQ) activities for autoclaves, parts washers, and related GMP process equipment.
• Prepare, execute, review, and maintain validation documentation, including protocols, reports, risk assessments, and test scripts.
• Collaborate with Engineering, Manufacturing, Quality Assurance, Validation, and Operations teams to support qualification and validation activities.
• Support data analysis from qualification studies and assist with deviation investigations and CAPA implementation where required.
• Ensure qualification documentation is completed in accordance with GMP, FDA, EMA, and internal quality requirements.
• Support change controls, deviation investigations, and regulatory inspection readiness activities related to validated equipment and processes.
• Review equipment operating parameters and qualification requirements to support validation readiness.
• Participate in commissioning, qualification, and validation activities for new or modified equipment.
• Maintain validation lifecycle documentation and ensure records remain accurate and inspection-ready.
• Assist with continuous improvement initiatives related to equipment qualification, process validation, and compliance activities.

Preferred Experience

• Bachelor’s degree in Engineering, or related field (preferred).
• Strong vendor management, process and manufacturing, and equipment lifecycle management experience.
• Good organizational, problem-solving, and communication skills.