Biologics Process Engineer – Deviation & CAPA Expert

No deviation Pte Ltd; Singapore; On-site; SGD 70,000 - 110,000; Full time

Benefits offered by this job

Generous Leave

Health & Wellness

Professional Development

Inclusive Culture

Impactful Work

Job summary

No Deviation Pte Ltd in Singapore is seeking a Process Engineer to own manufacturing equipment and systems at a biologics site. You will improve performance, reliability and cost-effectiveness, support deviation investigations, change controls and equipment qualification, and assist with regulatory inspections.

Join a team focused on Next Generation Manufacturing technologies, continuous improvement, and collaboration across Manufacturing, Quality, and Validation.

Qualifications

• Bachelor's degree in Engineering (Chemical, Biochemical, Mechanical or related discipline)
• 4 to 7 years of relevant experience in biologics, biotech and pharmaceutical manufacturing
• Working knowledge of cGMP in a regulated environment
• Experience leading deviation investigations and root cause analysis, and developing CAPA
• Experience initiating and managing change controls of moderate to complex scope
• Familiarity with equipment commissioning, qualification and validation
• Ability to troubleshoot equipment, automation and process issues in the field
• Knowledge of contamination control, cleanroom practices and environmental monitoring programmes
• Experience supporting regulatory inspections as SME

Responsibilities

• Recommend, design and implement equipment or system modifications
• Partner with cross-functional teams to implement operational improvements
• Troubleshoot equipment, automation and process issues of simple to moderate complexity
• Help introduce Next Generation Manufacturing technologies into the plant
• Lead deviation investigations and CAPA; manage change controls
• Prepare inspection materials and support regulatory inspections as SME
• Review batch records and identify digitalisation opportunities to improve processes

Skills

Process engineering

cGMP knowledge

Root cause analysis

CAPA

Change control

Equipment qualification

Validation

Data analysis

Technical writing

Cross-functional teamwork

On-call support

Regulatory inspections

Education

Bachelor's in Engineering

Job description

No Deviation Pte Ltd in Singapore is seeking a Process Engineer to own manufacturing equipment and systems at a biologics site. You will improve performance, reliability and cost-effectiveness, support deviation investigations, change controls and equipment qualification, and assist with regulatory inspections.

Join a team focused on Next Generation Manufacturing technologies, continuous improvement, and collaboration across Manufacturing, Quality, and Validation.