Process Engineer (1 year/PHARMA MNC) - North/up to $8k #HAO

Recruit Express Pte Ltd.; Singapore; On-site; SGD 81,000 - 97,000; Full time

Job summary

Recruit Express Pte Ltd is hiring a Process Engineer for a 1 year contract in the North region of Singapore, offering up to SGD 8,000 per month. The role focuses on leading Quality Event (Deviation) processes, Change Control, and CAPA with cross-functional teams including MSAT, Automation, and Engineering.

The candidate should have a degree in Life Sciences or Engineering and at least 5 years of bioprocess operations experience, with strong knowledge of deviations and regulatory requirements.

Qualifications

• Min degree in Life Sciences/Engineering with at least 5 years in upstream/downstream bioprocess operations and deviation experience.
• Experience in deviation and change control in biopharma industry.
• Ability to lead Quality Events and CAPA to closure.
• Strong cross-functional collaboration with MSAT, Automation, and Engineering teams.
• Familiarity with IQ/OQ/PQ and vendor turnover activities.

Responsibilities

• Raise and lead Quality Event (Deviation) processes and ensure timely creation, analysis and closure of events.
• Raise and lead Change Control for equipment/facility changes.
• Own and implement CAPAs identified from deviation investigations.
• Troubleshoot equipment and perform preliminary troubleshooting with Maintenance.
• Coordinate with Automation, MSAT, and manufacturing for improvements.
• Review vendor turnover, construction turnover, and functional specifications.
• Involve software FAT with PCS7, if applicable; participate in commissioning and qualification of new/modified equipment.
• Assist Validation with IQ/OQ/PQ execution.

Skills

Quality Event Management

Deviation Handling

Change Control

CAPA

Cross-functional collaboration

PCS7

IQ/OQ/PQ

Education

Degree in Life Sciences/Engineering

Tools

PCS7

Job description

Recruit Express will never request for your Singpass details in our recruitment process. Please contact us at 6732 6006 or email to [e-mail] if you are unsure if it is a scam.

Process Engineer (1 year/PHARMA MNC) - North/up to $8k #HAO

Salary: up to $8000

Duration: 1 year contract

Working Days & Hours: Mon-Fri Office Hours

Job Description

• Raise and Lead the Quality Event (Deviation) process and ensure timely creation, analysis and closure of events
• Raise and lead Change Control for implementation of changes to equipment / facilities
• Own and implement projects to address Corrective Actions / Preventative Actions (CAPA) identified as part of deviation investigations.
• Troubleshoot and fault find equipment’s which are not operating to expected parameters when identified and post preliminary troubleshooting by Maintenance.
• Timely closure of EHS and Quality event investigation and Corrective Actions / Preventative Actions (CAPA) tasks
• Participate as Process Engineering representative on cross functional support team meetings.
• Coordinates with Automation team and also with manufacturing and MSAT team for improvements or implementing changes
• Work with Engineering consultant firms, together with process engineers to support and complete the following tasks within the schedule for new equipment’s/existing modified equipment’s:
• o Involve Inspection Site installation of new equipment
• o Review of Vendor Turnover Packages and Construction Trade Turnover Packages.
• o Review Functional specifications
• o Participate in Software FAT using PCS7, if applicable.
• o Involve Commissioning and Qualification of new/Modified equipment in Cell Culture or Downstream (Purification) areas. Which includes reviewing/executing C&Q documents.
• Assist Validation Department with execution of qualification protocols including IQ, OQ, and PQ
• Target Delivery of results right first time
• Responsibility to adhere to any applicable EHS requirements.
• Commitment to a fair and respectful relationship to others and behavior in accordance with Code of Conduct.
• Any other duties as assigned by Takeda process engineering team members / Manager.

Job Requirements

Job Requirements: Min Degree in Life Sciences/Engineering or similar w relevant min 5 yrs experience inUpstream/Downstream bioprocess operations & Deviation and change control exp. in biopharma industry

Recruit Express Pte Ltd (Healthcare & Lifescience)