Technical Specialist ( 1 year contract | up to $7,000| Biologics MNC) #HAC

Job Scope:

* Support Manufacturing Operations across Readiness, Run and Release activities within a GMP biologics manufacturing environment.

* Lead and support deviation investigations, non-conformities, abnormalities and manufacturing events arising from production activities.

* Perform detailed Root Cause Analysis (RCA) using methodologies such as 5 Whys, Fishbone/Ishikawa, FMECA, causal/event analysis and fault-tree analysis.

* Assess product/batch impact and quality impact arising from manufacturing deviations and determine appropriate investigation outcomes.

* Develop and implement appropriate CAPAs, including effectiveness checks, to prevent recurrence.

* Ensure deviations and quality events are accurately documented, technically justified and closed within required timelines to support batch/lot disposition.

* Collaborate closely with Manufacturing, MSAT, QA, QC, Engineering, Validation and other SMEs during investigations.

* Prepare and review technical investigation reports, manufacturing documentation, Master Batch Records (MBRs), SOPs, Change Requests and risk assessments.

* Support deviation assessment and rating at Deviation Review Boards (DRB).

* Participate in customer and regulatory audits, presenting investigation findings, deviations, CAPAs and related quality documentation where required.

* Support technology transfers, process campaigns, operational readiness and manufacturing process improvements.

* Identify opportunities for continuous improvement, process robustness and manufacturing efficiency.

* Work cross-functionally to troubleshoot manufacturing issues and drive assigned investigations/projects to completion

Requirements:
* Diploma / Degree in a related Science or Engineering discipline such as Biotechnology, Biological Science, Chemistry, Biomedical Engineering, Chemical Engineering
* Able to commit to 1 year contract

All qualified candidates, please send your resume to [email protected]

Anna Chen jiaxin
CEI No: R25157621
Recruit Express Pte Ltd
EA License: 99C4599