Kenny-Whelan, a specialist division of the CPL group, is recruiting for a TECHNICAL OPERATIONS SPECIALIST for a contract position at our US biopharma client's site in Brinny, West Cork.
New Vacancy May 2025
Contact Jenn Dinan at 0214665408 or email jdinan@kenny-whelan.ie
Must already be eligible to work on a contract in the Republic of Ireland, i.e., possess a valid work permit with at least 11 months remaining.
Role: 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 that require process and operational knowledge.
2. Support process operations, troubleshoot technical and process-related issues, and lead investigations using MPS principles such as DMAIC, A3, and OPPS.
3. Manage EHS and Quality investigations, coach staff, and oversee batch record reviews.
4. Lead cross-functional technical projects to develop the Vaccine Process.
5. Support and manage process robustness changes and product introductions.
6. Lead cross-functional project teams for troubleshooting and investigations within Vaccines IPT and across the site as needed.
7. Act as Vaxneuvance Point of Contact (POC) for site compliance initiatives.
8. Provide high-level process knowledge to supporting functions and projects.
9. Support material management and troubleshooting with a focus on cost efficiency.
10. Apply Lean Six Sigma and Lean methodologies.
11. Represent the department on cross-functional project teams.
12. Adhere to the highest standards for compliance, including safety, quality, and cost.
13. Participate in and comply with manufacturing division Quality Management System (QMS) requirements, taking ownership as appropriate.
Skills Needed
1. Honours Degree or Masters in Science or Engineering (preferably Biotechnology).
2. More than 4 years of experience in a biopharmaceutical/vaccines environment.
3. Knowledge of material management systems and experience with Single Use Technology, including operational use, problem-solving, and vendor engagement.
4. Experience in manufacturing with a problem-solving mindset, preferably in Vaccine Drug Substance.
5. Strong technical and process knowledge in drug substance processing, including UF/DF, Lyophilisation, Bottle Filling, PAT, and Single Use Technology deployment.
6. Excellent collaboration and project management skills, with the ability to build relationships, resolve conflicts, and develop creative solutions.
7. Knowledge of FDA and HPRA regulations and standards relevant to biopharmaceuticals and vaccines.
8. Proven success working in cross-functional teams.
9. Ability to solve complex technical problems and apply existing solutions creatively.
10. Stakeholder management skills across multiple decision-makers and teams.
11. Ability to work independently with minimal guidance.
12. Experience in forecasting, planning, and monitoring costs related to material consumption.
All applications will be handled with the utmost confidentiality.
Contact Jenn Dinan at 0214665408 or apply via the link below.
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