Manufacturing Process Specialist

4 weeks ago

Cork, Cork, Ireland Fastnet Full time

Are you passionate about continuous improvement and hands-on support in pharmaceutical manufacturing? Our global client in Cork is looking for a Manufacturing Process Specialist to join their high-performing team. This is a fantastic opportunity for someone with strong GMP experience who thrives in a dynamic, shop-floor environment and is ready to take their career to the next level.

In this role, you'll be the go-to expert for production support, collaborating directly with manufacturing teams to ensure safe, compliant, and timely batch execution. You'll also play a key role in maintaining and improving critical process documentation and controls.

Responsibilities:

  • Provide day-to-day technical support to manufacturing teams, ensuring batches are executed safely, efficiently, and in compliance with GMP and regulatory standards.
  • Serve as the process SME for your assigned products, maintaining accurate and up-to-date Master Batch Records, Bills of Materials, Recipes, and related documentation.
  • Monitor and verify that all critical process parameters remain within defined limits.
  • Lead or support process change activities, ensuring robust change control procedures are followed.
  • Contribute to risk assessments and hazard analyses (e.g., QRA, ZHA) for assigned processes.

Requirements:

  • A degree in Engineering, Chemistry, Pharmacy, Pharmaceutical Technology, or a related scientific field.
  • At least 3 years' experience in a GMP manufacturing environment, ideally in a process support or technical operations role.
  • A strong understanding of pharmaceutical processes, quality systems, and regulatory expectations.
  • A proactive mindset and a passion for process optimisation and problem-solving.
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