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Kenny-Whelan (a specialist division of the CPL group) is recruiting a TECHNICAL OPERATIONS SPECIALIST for a contract position at our US biopharma client's site in Brinny, West Cork.
New Vacancy - May
Contact Jenn Dinan by phone or email.
Eligibility: Candidates must already be eligible to work on a contract in the Republic of Ireland, with a valid work permit for at least 11 months.
Position: TECHNICAL SPECIALIST IN OPERATIONS – VACCINES IPT.
The Technical Specialist will provide process technical support to the Vaccines IPT team and other site departments requiring Vaccine Process knowledge. The role reports to the Vaccines IPT Associate Director.
Responsibilities
1. Support department and site-level activities requiring process and operational knowledge.
2. Support process operations, troubleshoot technical and process-related issues, and lead investigations using MPS principles such as DMAIC, A3, OPPS, etc.
3. Manage EHS and Quality investigations, coaching, complete and oversee batch record reviews.
4. Lead cross-functional technical projects to develop the Vaccine Process further.
5. Support and manage Process Robustness changes and product introductions.
6. Lead cross-functional teams in troubleshooting and investigations within Vaccines IPT and across the site.
7. Serve as Vaxneuvance POC for site compliance initiatives.
8. Provide high-level process knowledge to supporting functions and projects.
9. Support and troubleshoot material management with a focus on cost.
10. Apply Lean Six Sigma and Lean methodologies.
11. Represent the department on cross-functional project teams.
12. Adhere to high standards for Compliance (Safety, Quality, Cost).
13. Participate in and comply with the Manufacturing Division Quality Management System (QMS) requirements, including ownership where relevant.
Skills Needed
1. Honours Degree or Master's in a Science or Engineering discipline, preferably Biotechnology.
2. More than 4 years' experience in a biopharmaceutical/vaccines environment.
3. Knowledge of material management systems and direct experience with Single Use Technology, including operational use, problem solving, and vendor engagement.
4. Experience in manufacturing, preferably in Vaccine Drug Substance, with a problem-solving mindset.
5. Strong technical and process knowledge in drug substance processing unit operations like UF/DF, Lyophilisation, Bottle filling, PAT, and Single use technology deployment.
6. Excellent collaboration and project management skills, capable of building relationships at all levels, resolving conflicts, and devising creative solutions.
7. Knowledge of FDA / HPRA Regulations and standards for Quality and Regulatory requirements in the biopharmaceutical/vaccine sector.
8. Proven success in cross-functional teams and project environments.
9. Ability to solve complex technical problems with innovative perspectives.
10. Effective stakeholder management with decision-makers, colleagues, and teams.
11. Ability to work independently with minimal guidance.
12. Experience in forecasting, planning, and monitoring material costs.
All applications will be handled with the utmost confidentiality.
Contact Jenn Dinan or apply via the link below.
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