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

Discussion

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

See also

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