Downstream Manufacturing Engineer

AMC 21598

Downstream Manufacturing Engineer (Drug substance)
11 month contract
On site - Swords (Hybrid role)


We are looking for a Downstream manufacturing Engineer to work with the Days Operations Team at a world leading biopharmaceutical manufacturer based in North Dublin.


To be successful in this role you MUST have three years' experience in a pharmaceutical environment (preferably drug substance) including GMP change management and Quality Investigation Writing experience.

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 standardization 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 centered 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.

• 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)
• Experience in change management in a GMP environment.
• Experience in technical writing for GMP documentation and quality investigations.
• Experiences across multiple site functions (including but not limited to Quality, Engineering, or Supply Chain) desirable but not required.
• Experience working with GMP Documentation Management Systems