Manufacturing Operations Specialist

1 week ago

Portlaoise, Laois, Ireland Next Generation Recruitment Full time
Company Overview:
The Next Generation Recruitment is a leading global pharmaceutical company with a state-of-the-art facility in Carlow. We are committed to innovation and excellence in the field of biopharmaceutical manufacturing.

About the Role:
We are seeking a skilled Process Engineer to join our team at the Carlow site. As a Process Engineer, you will play a key role in ensuring compliance with cGMP and driving continuous improvement in manufacturing operations.

Key Responsibilities:
1. Provide technical support for manufacturing and new product introduction.
2. Design, review, and execute process simulation studies for new product introduction and ongoing manufacturing.
3. Provide technical input into quality notifications, investigations, and deviations.
4. Lead and participate in system failure investigations, root cause analysis, and CAPA implementation.
5. Execute and develop change controls to support process simulations.
6. Represent technical operations at global technical forums.
7. Ensure compliance with global policies, regulatory requirements, and cGMP.
8. Work cross-functionally with internal teams and external vendors.
9. Drive a safety-first, compliance-driven culture.

What You Need to Succeed:
1. Degree qualified in Science, Engineering, or another technical discipline.
2. Experience in a sterile/aseptic manufacturing environment (preferred).
3. Knowledge of sterile filling processes, equipment validation, and process simulations.
4. Experience with regulatory compliance, quality investigations, and risk management.
5. Strong problem-solving, troubleshooting, and data analysis skills.
6. Proficiency in Microsoft Office and job-related applications.
7. Ability to lead and influence cross-functional teams.
8. Strong communication, presentation, and project management skills.

Benefits:
- Work in a world-class biopharmaceutical facility.
- Be part of an innovative, collaborative, and fast-paced team.
- Opportunities for career growth and professional development.
- Competitive salary and benefits package.

The Next Step:
If this position interests you, please apply through LinkedIn with an up-to-date CV to Jessica from Next Generation Recruitment or call us on the main line.

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