ERF CertRP | Talent Solutions Specialist | Sourcing & Developing Life Sciences Talent
Summary:
A Process Engineer is required to join the Process Engineering Group on-site at a biopharmaceutical company in Carlow. The successful candidate will provide technical support for new product introductions (NPI) and commercial manufacturing.
Responsibilities
* Design/Author/Review/Approve/Execute qualification/validation documentation and process development studies in line with the standard approval process.
* Design/Author/Review/Approve/Execute Execution/development of change controls.
* Contribution to Kaizen events as appropriate.
* Technical input into quality notification by authoring/reviewing/approving investigations.
* Execution of equipment/qualification validation programs; including re-qualification and re-validation.
* Support continuous improvement through Lean Six Sigma methodologies.
* Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
* Serve as technical engineering representative for internal technical group discussions and represent technical Operations at global technical forums.
* 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.
* Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participating in audits and inspections and proactively highlighting any issues around compliance.
Qualifications & Experience
* Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
* Min 3 years’ experience, ideally in manufacturing, preferably GMP setting.
* Demonstrable experience in leading technical-related projects.
* Evidence of continuous professional development is desirable.
* Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable, but not a necessity.
* Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
* Report, standards, and policy writing skills required.
* Equipment and process validation.
* Sterile filling processes and equipment.
* Proficiency in Microsoft Office and job-related computer applications required.
* Hybrid role, once successful completion of training. Occasional shift support as required based on program needs.
Seniority level
* Associate
Employment type
* Contract
Industries
* Pharmaceutical Manufacturing
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