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PE Global is currently recruiting for a Process Engineer for a leading multi-national Biotech client based in North Dublin.
This is an initial 11-month contract position.
Responsibilities
* Work as a key team member within the Downstream (DS) Integrated Process Team (IPT) to ensure on-time delivery of the production schedule while maintaining alignment with site safety and quality standards.
* Provide oversight on material management, ensuring quality and delivery metrics related to material management are always maintained.
* Own Quality Investigation from identification through root cause analysis
* Provide oversight on day-to-day production quality metrics ensuring on-time documentation closure, line clearance and material management as per area SOPs.
* Drive continuous improvement projects related to schedule, equipment, and delivery capability within the DS IPT.
* Act as a link between the shift operations team and days team, ensuring standardisation and integration between all IPT teams.
* Support audit readiness in the BDS and drive a permanent audit readiness culture within the team.
* Direct Root Cause Analysis (RCA) sessions for both safety and quality related events, driving actions to closure with appropriate corrective/preventive measures.
* Drive MPS standards within the area and ensure team alignment on same.
* Lead/support area change controls, CAPAs, QSAT actions as relevant per work stream as well as completing documentation updates as required.
* Provide ongoing coaching and support to cross functional team members, to share process and operational best practices.
* Act as days operations member on process centred teams(PCT), working with technical operations and shift operations to identify, perform root cause analysis and develop corrective/ preventative actions for issues as they are occur.
Requirements
* A Level 7 Degree in Science, Engineering or other relevant disciplines/ relevant experience.
* At least 3 years’ experience in the Pharmaceutical industry (preferably in Drug Substance)
* Experiences across multiple site functions (including but not limited to Quality, Engineering, or Supply Chain) desirable but not required.
* Experience in change management in a GMP environment.
* Experience in technical writing for GMP documentation and quality investigations.
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