Kenny-Whelan, a specialist division of the CPL group, is recruiting a Technical Operations Specialist for a contract based at our US biopharma client's site in Brinny West Cork.
Job Description:
We are seeking an experienced Technical Operations Specialist to provide process technical support to the Vaccines IPT team and other site departments requiring Vaccine Process knowledge.
The role will involve reporting to the Vaccines IPT Associate Director and will be responsible for supporting department and site level activities that require process and operational knowledge.
* Support process operations, including troubleshooting technical and process-related issues, and leading investigations utilizing MPS principles (DMAIC/A3/OPPS).
* Manage EHS and Quality investigations, coaching, completing, and overseeing batch record reviews.
* Lead cross-functional Technical Projects to further develop the Vaccine Process.
* Support and manage Process Robustness changes and product introduction.
* Lead cross-functional Projects problem-solving teams for troubleshooting and investigations within Vaccines IPT and across the site as required.
* Vaxneuvance POC for site compliance initiatives.
The successful candidate will be responsible for providing a high level of process knowledge to supporting functions and projects. Additionally, they will support and lead material management and troubleshooting with a cost focus.
Applicants should have a strong understanding of Lean Six Sigma and Lean methodologies, as well as experience working in a biopharmaceutical or vaccine environment.
Awarding the highest standards for Compliance (Safety, Quality, and Cost), the successful candidate will ensure the highest Quality, Compliance, and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements.
Requirements:
* Honors Degree or Master's in a Science or Engineering discipline (preferably Biotechnology).
* > 4 years' experience in a biopharmaceutical/vaccine environment.
* Knowledge in material management and associated systems.
* Direct experience with Single Use Technology, i.e., operational use, problem-solving, vendor engagement.
* Direct experience in manufacturing with a problem-solving mindset.
* Strong technical and process knowledge with background and experience in drug substance processing unit operations, including UF/DF, Lyophilisation, Bottle filling, PAT, Single-use technology deployment.
* Strong collaboration and project management skills, able to establish good working relationships with employees at all levels, resolve conflict, and provide feedback, and devise and implement creative solutions to problems.
* Knowledge of FDA / HPRA Regulations and applicable standards for Quality and Regulatory requirements within the biopharmaceutical/vaccine area.
* Demonstrated successes in a cross-functional team environment, such as project teams.
This is a contract-based position, and the ideal candidate will be eligible to work on a contract in the Republic of Ireland.
Contact Jenn Dinan via email for more information and to apply for this exciting opportunity.