Process Engineer – Pharmaceutical Manufacturing
Location:
Carlow, Ireland |
Contract:
11 months (extendable) |
Shift:
Occasional shift support required
About the Role:
We are seeking a Process Engineer to join the Process Engineering Group at our Carlow site, reporting to the Technical Engineering Manager. This role provides technical support for new product introduction (NPI) and commercial manufacturing, ensuring operational excellence and compliance. The successful candidate will participate in or lead cross-functional teams, liaise with vendors, and contribute to global technical forums.
Key Responsibilities:
* Support NPI and commercial manufacturing through technical expertise, including technology transfers.
* Design, author, review, approve, and execute process and equipment qualification/validation documentation.
* Develop, review, and execute change controls, and contribute to Kaizen and continuous improvement initiatives.
* Provide technical input for quality notifications and investigations.
* Perform root cause analysis for system failures or substandard performance, implementing corrective actions.
* Represent the Carlow site in internal technical discussions and global technical forums.
* Ensure compliance with GMP, regulatory requirements, and internal policies through documentation, risk assessments, and proactive monitoring.
* Collaborate to maintain a safe, compliant, and efficient working environment.
* Provide shift support as required for program needs.
Skills & Experience Required:
* Bachelor's degree or higher in Science, Engineering, or a related technical discipline.
* Minimum 3 years' experience in manufacturing, ideally in a GMP environment.
* Demonstrable experience in technical projects, NPI, or technology transfer.
* Knowledge of process monitoring systems, automation systems (DeltaV), and operational intelligence/data systems (Pi System) is advantageous.
* Understanding of Irish, European, and international regulatory requirements and GMP standards.
* Experience in equipment and process validation, sterile filling processes, and quality documentation.
* Proficiency in Microsoft Office and job-related software applications.
* Excellent communication, presentation, and interpersonal skills.
What We Offer:
* Exposure to diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation.
* Opportunity to contribute to continuous improvement and innovation in manufacturing processes.
* Hybrid working model with on-site presence and occasional shift support as required.