Biopharma Process Engineer: Deviation & Change Control

RECRUIT EXPRESS PTE LTD; Singapore; On-site; SGD 67,000 - 89,000; Full time

Job summary

RECRUIT EXPRESS PTE LTD in Singapore invites a biochemical/biopharma professional to lead deviation investigations and Change Controls within a GMP environment. You will troubleshoot process equipment, support commissioning and qualification activities (IQ/OQ/PQ), and review engineering docs.

The role requires 3–5+ years in pharmaceutical/biopharmaceuticals, strong CAPA management, and familiarity with cGMP.

Qualifications

• 3–5+ years of relevant experience in Pharmaceutical/Biopharmaceutical industries.
• Strong experience in Deviation Investigation and Change Control.
• Good understanding of cGMP manufacturing and process equipment; upstream/downstream bioprocess experience preferred.
• CAPA management and timely closure of quality events.

Responsibilities

• Lead deviation investigations and Change Controls.
• Manage CAPAs and ensure timely closure of quality events.
• Troubleshoot process equipment and support engineering improvements.
• Support commissioning & qualification activities (IQ/OQ/PQ).
• Review P&IDs, URS and engineering documentation.
• Support Cell Culture / Purification process equipment projects.

Skills

Deviation Investigation

Change Control

CAPA Management

Process Equipment Troubleshooting

IQ/OQ/PQ

P&IDs & URS Review

Biopharma Experience

Education

Bachelor's degree

Tools

URS Documentation

P&IDs Review

Job description

RECRUIT EXPRESS PTE LTD in Singapore invites a biochemical/biopharma professional to lead deviation investigations and Change Controls within a GMP environment. You will troubleshoot process equipment, support commissioning and qualification activities (IQ/OQ/PQ), and review engineering docs.

The role requires 3–5+ years in pharmaceutical/biopharmaceuticals, strong CAPA management, and familiarity with cGMP.