Process Engineer (Ms&T) X 4

Overview

Asset Recruitment is recruiting 4 Process Engineers for contract positions, on behalf of our client, a leading global biopharmaceutical in their site in Swords.

Process Engineer (MS&T) – 4 positions

Responsibilities

Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.

Design / Author / Review / Approve / Execute qualification documentation in line with the standard process.

Lead experimental design of studies, execution, data analysis and interpretation.

Authors and reviews batch documentation, regulatory and technical documentation.

Lead multidisciplinary teams for process improvement and troubleshooting with end-to-end product focus through Lean Six Sigma methodologies.

Lead and facilitate investigations, ensuring effective Root Cause Analysis and CAPAs.

Participate in audits and inspections.

Interpret trends observed in commercial process monitoring (e.g., proactive process analysis (PPA), continued process verification (CPV), statistical process control (SPC) multivariate analyses (MVDA)), and support further technical investigations and process changes to drive improvements in yield and robustness.

Support the execution of development and PPQ batches, change control management and implementation.

Requirements

Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.

Demonstrated leadership and change management skills.

Proven track record of delivering high performance through development and coaching of a team.

Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work / upskill / coach a team environment.

Experience leading technical projects.

Experience with upstream cell culture and / or downstream purification of biological molecules.

Experience with technology transfer, regulatory filing and commercial drug substance manufacturing of biologics is a plus.

Technical operations experience in the drug substance manufacture of biological molecules at commercial scale.

Experience in change management, deviations and CAPAs management.

Experience in preparing for and presenting in front of regulatory audits as SME.

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