Job Title: Operations Process Support Specialist
This is a fantastic opportunity to work on state-of-the-art fill-finish facilities and contribute to the company's first stand-alone vaccine and biologics plant outside the US.
Key Responsibilities:
* Serve as a technical representative for established manufacturing processes and new product introduction.
* Collaborate within cross-functional teams and partner with colleagues to perform vendor management, communications, training, project work, audit/inspection duties, and ensure department readiness for audits/inspections.
* Design, author, review, approve, and execute process updates in support of ongoing manufacturing support and new product introduction.
* Provide technical input into quality notifications by authoring, reviewing, and approving investigations.
* Drive continuous process improvements using Lean Principles to optimize equipment uptime and target outputs.
* Oversee operations processes to ensure continuous, reliable, and repeatable manufacturing.
* Drive effective writing, revising, and rolling out of accurate operational procedures, training materials, and manufacturing procedures.
Requirements:
1. Bachelor's Degree or equivalent, ideally in a Science, Engineering, or other Technical discipline.
2. Proven track record and established experience in a process engineer role with measurable accomplishments and achievements.
3. Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably in a GMP setting.
4. Knowledge of regulatory and code requirements to Irish, European, and International Codes, Standards, and Practices.
5. Proficiency in report, standards, and policy writing.