Manufacturing Process Development Specialist

2 weeks ago

Carlow, Ireland beBeeProcess Full time €60,000 - €90,000
Job Title:

Project Engineer

Job Description

This is an exciting opportunity to work on a state-of-the-art fill-finish facility and the company's first stand-alone vaccine and biologics plant outside the US.

The successful candidate will lead and execute production floor-based activities, participate on a team of engineers, plan and execute C&Q, validation activities as required, design and develop engineering studies, provide technical input into quality notification by authoring/reviewing/approving investigations, and perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.

Additionally, the Process Engineer will support continuous improvement through Lean Six Sigma methodologies, leading and active participation in projects, system failure investigations, and investigation reports, as well as perform root cause analysis of system failures, substandard performance, using standard tools and methods.

Required Skills and Qualifications
  • 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
Benefits

Working with a renowned pharmaceutical client offers a chance to contribute to life-changing oncology treatments. The position also provides opportunities for professional growth and development in a dynamic and innovative environment.

Others

Applicants should be prepared to interface effectively with all levels of colleagues and external customers. Excellent communication, presentation, and interpersonal skills are essential for this role.

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