Pharma Process Engineer: Change Control & CAPA Lead

RECRUIT EXPRESS PTE LTD; Singapore; On-site; SGD 78,000 - 123,000; Full time

Job summary

RECRUIT EXPRESS PTE LTD is seeking a Process Engineer in Singapore to lead and support Change Control activities for equipment and facility modifications within a cGMP environment.

You will investigate Quality Events/Deviations, perform root cause analysis, and implement CAPAs while coordinating with Engineering, Manufacturing, Automation and MSAT teams on process improvements and new equipment installations.

Qualifications

• Hands-on experience managing Change Controls, Deviations and CAPA within a cGMP environment.
• Good communication and stakeholder management skills with the ability to work effectively across Engineering, Manufacturing, Automation, MSAT and Validation teams.
• Prior pharmaceutical/biopharmaceutical industry experience is required.

Responsibilities

• Lead and support Change Control activities for equipment and facility modifications, ensuring timely implementation and closure.
• Raise, investigate and manage Quality Events / Deviations, including root cause analysis and timely closure of investigations.
• Develop and implement Corrective and Preventive Actions (CAPA) arising from deviation investigations.
• Troubleshoot production equipment and process issues to identify technical causes and implement appropriate solutions.
• Support commissioning and qualification activities for new and modified equipment within Cell Culture and Purification manufacturing areas.
• Draft, review and execute commissioning and qualification documentation and protocols.
• Review engineering documentation including P&IDs, User Requirement Specifications (URS), functional specifications and technical drawings.
• Coordinate with Automation, Manufacturing and MSAT teams on process improvements, equipment changes and technical initiatives.
• Work closely with engineering consultants and cross-functional teams on new equipment installations and modifications.
• Support Validation activities, including execution of IQ, OQ and PQ protocols.
• Ensure timely closure of EHS and Quality investigations and associated CAPA actions.
• Ensure engineering activities comply with cGMP, Good Engineering Practices (GEP), EHS requirements and applicable quality standards.
• Participate as the Process Engineering representative in cross-functional meetings and projects.

Skills

Quality management

Root cause analysis

Stakeholder management

cGMP knowledge

CAPA handling

Education

Degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Mechanical Engineering or related engineering discipline

Job description

RECRUIT EXPRESS PTE LTD is seeking a Process Engineer in Singapore to lead and support Change Control activities for equipment and facility modifications within a cGMP environment.

You will investigate Quality Events/Deviations, perform root cause analysis, and implement CAPAs while coordinating with Engineering, Manufacturing, Automation and MSAT teams on process improvements and new equipment installations.