Process Engineer


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Location: Dublin

Type: Contract

Rate: Negotiable


Reference: Process1

Updated: 19/02/2018 15:40:43

The Process Engineer will be based in our Clients Technical Services function and will provide the following main duties:

•Provide proactive and reactive technical process support to sustain Manufacturing operations, partnering with Engineering, Manufacturing, Supply Chain & QA colleagues as necessary
•Using a data-driven approach, continuously improve and trouble-shoot manufacturing process performance to achieve optimum OEE, process capability and capacity.
•Lead continuous improvement project teams. Utilise product, process and input material data, knowledge of critical quality attributes and critical process parameters to enable risk-based continuous process improvement and change management.
•Lead or participate in New Product Introduction and Technology Transfer project teams with focus on process development, knowledge transfer and process risk assessments. Partner with Global Scientific Affairs - product and device teams.
•Support capital projects with early involvement in change evaluation and process risk assessments.
•Lead and support the Operational Excellence programme on the site and implement improvements. Apply Lean, 6-Sigma and other tools to troubleshoot and problem-solve process issues to deliver Continuous Improvement to increase process capability and capacity.
•Manage the site Continued Process Verification (CPV) program, analysing Critical Process Parameters (CPP’s) and Critical Qualify Attributes (CQA’s), to ensure processes are in control and capable.
•Routinely review the control strategy for suitability, based on Continued Process Verification (CPV) output and information gained from non- conformances, quality incidents, CAPA’s etc.

Skills Required:

•Mechanical/Mechatronic/Chemical/Quality Engineering graduate.
•Five years + experience in a similar role within the Pharma/Medical Device or related industries.
•Experience of Dry Powder Inhalers, powder handing, component moulding and assembly would be advantageous.
•A working understanding of appropriate regulatory requirements, including 21 CFR Parts 210/211, ISPE/ICH Guidelines (including ObD enhanced approach) and EudraLex would be an advantage
•Lean/Six sigma certification would also be advantageous.

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