18468-Process Engineer (Downstream Manufacturing)-Dublin Contractor

This role is an 11 Month Hybrid contract with a view to extension.

3/4 Days on site 1/2 Remote.

Purpose

Downstream Manufacturing Engineer working with Days Operations support team.

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 maintained at all times.
Complete downtime analysis and trending for respective areas 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 DS IPT.
Act as a link between the shift operations team and the day’s 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, and QSAT actions as relevant per work stream as well as completing documentation updates as required.
Manage and update BOMs per assigned workstream.
Provide ongoing coaching and support to cross-functional team members, to share the process and operational best practices.

Requirements

A Level 7 Degree in Science, Engineering, or other relevant disciplines/ relevant experience.
At least 3 years of 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 the development and coaching of a team.
Desirable evidence of Continuous Professional Development.
Self-motivated with excellent organizational skills
Excellent verbal and written communication skills
Ability to work independently and as part of a team in a cross-functional collaborative environment
High level of attention to detail
Experience working with GMP Documentation Management Systems
Proficient in Microsoft Office Tools (word/excel/PowerPoint )
Good interpersonal skills