Process Engineer Job Description
This is an exciting opportunity to join our team as a Process Engineer at PE Global, working with a leading multi-national Biotech client based in North Dublin.
The role is initially an 11-month contract position.
Responsibilities
* Work closely with the Downstream Integrated Process Team (IPT) to ensure timely delivery of production schedules while maintaining site safety and quality standards.
* Oversee material management, ensuring quality and delivery metrics are consistently met.
* Lead quality investigations from identification to root cause analysis.
* Monitor and improve day-to-day production quality metrics, including on-time documentation closure, line clearance, and material management according to area SOPs.
* Drive continuous improvement projects related to schedule, equipment, and delivery capability within the DS IPT.
* Foster collaboration between shift operations and days teams, promoting standardization and integration across all IPT teams.
* Support audit readiness in the BDS and drive a culture of permanent audit readiness within the team.
* Conduct Root Cause Analysis (RCA) sessions for safety and quality-related events, implementing corrective/preventive measures.
* Establish and enforce MPS standards within the area, ensuring team alignment.
* Lead/support area change controls, CAPAs, QSAT actions, and document updates as necessary.
* Provide coaching and support to cross-functional team members, sharing process and operational best practices.
* Act as a days operations member on process-centered teams, collaborating with technical operations and shift operations to identify and resolve issues.
Requirements
* A Level 7 Degree in Science, Engineering, or a relevant discipline, or relevant experience.
* At least 3 years' experience in the Pharmaceutical industry, preferably in Drug Substance.
* Experience across multiple site functions, including Quality, Engineering, or Supply Chain, is desirable but not required.
* Proven experience in change management within a GMP environment.
* Technical writing skills for GMP documentation and quality investigations.