LSC have a great contract opportunity for a Process Engineer to join a global Biopharmaceutical company in Carlow. This is a state-of-the-art vaccines and biologics manufacturing facility currently producing many products in various therapeutic areas including: oncology, autoimmunity, pneumonia, and infectious disease.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Support manufacturing activities through documentation generation, equipment and process investigations associated with non-GMP activities and completion of quality notifications.
- Provide input to the MES development process team on technical aspects of MES functionality and serve as MES SME within IPT
- Be a document system expert; this will include document review, approval and document system workflow expedition.
- Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOP's, SWI's, training documents, and change controls.
- Support operation activities through documentation generation, filing, tracking, auditing and efficient maintenance of all associated databases including the maintenance, auditing and archiving of the process documentation system.
- Support Batch release through timely Quality Notification completion, Interim/summary report generation; meeting batch release requirement.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
- Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably GMP setting.
- Sterile filling processes and equipment
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Adam Murphy at 0214777329 if you have any more questions about this opportunity!
