Process Development Specialist

3 days ago

Carlow, Ireland beBeeDevelopment Full time €60,000 - €80,000
Process Development Specialist Opportunity

We are seeking an experienced Process Development Specialist to support multiple capital projects on site.

About the Role:

The successful candidate will play a key role in supporting the construction of a state-of-the-art fill-finish facility and the company's first stand-alone vaccine and biologics plant outside the US. This is a fantastic opportunity for a skilled Process Development Specialist to join our team and contribute to the delivery of high-quality products.

Main Responsibilities:
  • Lead/execute production floor-based activities such as equipment qualification, validation, and re-validation.
  • Participate on a team of engineers to design, develop, and implement engineering studies.
  • Plan and execute C&Q activities as required.
  • Provide technical input into quality notifications by authorizing, reviewing, and approving investigations.
  • Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
  • Support continuous improvement through Lean Six Sigma methodologies.
  • Lead and participate in projects, system failure investigations, and investigation reports.
Requirements:
  • Bachelor's Degree or higher preferred; ideally in a Science, Engineering, or other technical discipline.
  • Prior related work experience; ideally in manufacturing, preferably GMP Setting.
  • Typically have 5 years related work experience in Aseptic manufacturing/process engineering.
  • Knowledge of regulatory/core requirements to Irish, European, and International Codes, Standards, and Practices.
  • Report, standards, policy writing skills required.
  • Equipment and process validation.
  • Sterile filling processes and equipment.
  • Proficiency in Microsoft Office and job-related computer applications required.
  • Lean Six Sigma Methodology experience desired.
  • Excellent communication, presentation, and interpersonal skills to interface effectively with all levels of colleagues and external customers in a team-oriented manner.

This is a fantastic opportunity for a skilled Process Development Specialist to join our team and contribute to the delivery of high-quality products. If you are a motivated and experienced professional looking to take your career to the next level, we encourage you to apply for this exciting opportunity.

What We Offer:
  • A competitive salary package.
  • A dynamic and supportive work environment.
  • Ongoing training and development opportunities.

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