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

Roles & Responsibilities

Salary: up to $8000

Duration: 1 year contract

Working Days & Hours: Mon-Fri Office Hours

Location: Kranji

Job Description:

Responsibilities

• 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 Review P&IDs, standard detail drawings, URS, etc.,

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

Interested candidates, please submit your resume to: allylok@recruitexpress.com.sg

Ally Audrey Lok Xin Woon

Recruit Express Pte Ltd (Healthcare & Lifescience)

Company EA Licence number : 99C4599

Personnel EA License: R21102307

Tell employers what skills you have

Conduct and Behaviour Management
coordinate manufacturing processes
CAPA
Timely Execution
Deviations
Troubleshooting Procedures
Delivering Results
Implementing Change
EES requirements
Execute validation protocols
Cross Functional Team Building
company processes
Preventive Actions
Consulting Engineering
Quality Assurance Processes
Change Control Management