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.