Downstream Manufacturing Engineer

Summary:
Our client is a biopharmaceutical company based in West Cork, looking for a Downstream Manufacturing Engineer working with the Days Operations support team.

Responsibilities:

• Work as a key team member within the Downstream (DS) Operations Team 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 maintained at all times.
• Complete downtime analysis and trending for respective area and drive improvement projects in conjunction with the technical operations team.
• 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 team.
• Act as a link between the shift operations team and days team, ensuring standardisation and integration between all Operations 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.
• Manage and update BOMs per assigned workstream.

Qualifications & Experience:

• 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.
• Proven track record of delivering high performance through development and coaching of a team.
• Experience working with GMP Documentation Management Systems.
• Proficient in Microsoft Office Tools (word/excel/PowerPoint).