About Your New Employer
- World leading Biopharma company, currently ranked in the Top 5 Biopharma companies globally.
- In Ireland, our client has been recognised as the Pharma Industry Company of the Year and is listed in the top 3 Best Large Workplaces in Ireland.
- You will be based in a state-of-the-art site which is a strategic facility in the global network.
About Your New Job
- The Technical Shift Lead will be tasked with leading, coaching and mentoring their team
- You will be responsible for the supervision and execution of filling, lyophilization, equipment preparation, formulation, buffer preparation and support processing activities in the biologics fill finish facility to meet clearly stated operating objectives.
- Promote a culture of contamination control and compliance with aseptic best practice.
- Liaise with functional leadership teams (Ops, Quality, Engineering, Supply Chain etc) on operational activities
- The Technical Shift will be tasked with providing technical expertise for investigation and resolution of process deviations, root cause investigation, CAPAs, process improvements, review, and approval of change controls
- Responsible for verification and update of manufacturing control system transactions accurately and in a timely fashion.
- Act as key point of technical contact for aseptic fill finish activities.
- The Technical Shift Lead will be tasked with liaising with program management, supply chain, technical operations quality, and engineering groups to ensure effective planning, scheduling, and execution of commercial and NPI clinical manufacturing.
- Responsible for driving operations excellences and Key operations targets including OEE where applicable.
- Provide direct interface as a subject matter expert with QA department to interaction with HPRA, FDA and applicable health authority and internal audits.
- Lead cross functional risk assessments and continuous improvement projects
- Ensure the execution of fill finish, lyophilization, equipment preparation, buffer preparation and formulation processing activities to meet clearly stated operating objectives.
- Work closely with the other Technical Shift Leaders to ensure interdepartmental activities are planned and executed safely.
What Skills You Need
- The candidate should have a Degree, Masters or PhD in Life Sciences, Process Engineering, Biopharmaceutical Engineering or Chemical Engineering discipline.
- 5 years’ experience in batch processing, automation, commissioning, and validation in an FDA/HPRA regulated industry and 1+ years team leadership experience.
- Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required for this role.
- Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality and safety requirements.
- Experience of start-ups and/or new product introductions to bio-pharmaceutical/pharmaceutical facilities (Biologics Preferred)
What’s on Offer
- Permanent position with a competitive salary.
- Annual Bonus.
- Career progression opportunities.
- Apply now by clicking the “Apply Now" button or call me, Ben Byrne on +353 1 4744688. Or if the job isn’t quite right but you are looking for something similar, please get in touch.
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