An exciting opportunity has arisen for a Process Engineer to join the our client’s Process Engineering Group in Carlow. Reporting to the Technical Engineering Manager, this role offers the chance to support new product introduction (NPI) and commercial manufacturing while contributing to continuous improvement initiatives in a dynamic environment.
This position is ideal for a motivated engineer with experience in manufacturing—preferably in a GMP setting—and a passion for innovation and problem-solving. Experience with technology transfer is highly desirable.
Key Responsibilities:
- Provide technical support for new product introduction and commercial manufacturing.
- Design, review, and execute qualification/validation documentation and process development studies.
- Lead and contribute to change control activities and Kaizen events.
- Conduct root cause analysis and support continuous improvement initiatives through Lean Six Sigma methodologies.
- Execute equipment and process validation, including re-qualification and re-validation.
- Provide technical input into quality notifications by authoring, reviewing, and approving investigations.
- Act as a technical representative in both local and global technical forums.
- Ensure compliance with cGMP, internal policies, and regulatory requirements.
- Support and promote a safe and compliant culture on site.
Key Skills & Experience:
- Bachelor’s Degree (or higher) in Science, Engineering, or another relevant technical discipline.
- Minimum of 3 years’ experience in manufacturing; GMP experience highly advantageous.
- Proven ability to lead technical projects and drive results.
- Knowledge of process monitoring systems, automation systems (DeltaV), and data/operational intelligence systems (Pi System) is desirable but not essential.
- Strong understanding of equipment and process validation, and knowledge of sterile filling processes is an advantage.
- Excellent communication, presentation, and interpersonal skills.
- Proficiency in Microsoft Office and related job-specific applications.
- Demonstrated commitment to continuous professional development.
- Hybrid working is available upon successful completion of training, with occasional shift support required based on program needs.
