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Recruitment Consultant - Life Science and Engineering at Berkley Group
Operations Specialist
An exciting opportunity has arisen for a 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, reporting to the Vaccines IPT Associate Director.
Responsibilities:
* Support department and site activities requiring process and operational knowledge.
* Assist in process operations, troubleshooting technical and process issues, and leading investigations using MPS principles such as DMAIC, A3, OPPS.
* Manage EHS and Quality investigations, coaching, batch record reviews, and oversee related activities.
* Lead cross-functional technical projects to develop the Vaccine Process.
* Support and manage process robustness changes and product introductions.
* Lead problem-solving teams within Vaccines IPT and across the site for troubleshooting and investigations.
* Provide high-level process knowledge to supporting functions and projects.
* Support material management and troubleshooting with a focus on cost efficiency.
* Apply Lean Six Sigma and Lean methodologies.
* Represent the department on cross-functional project teams.
* Ensure compliance with safety, quality, and cost standards.
* Participate in and adhere to the Manufacturing Division Quality Management System (QMS) requirements.
Basic Qualifications:
* Honours or Master's Degree in Science or Engineering (preferably Biotechnology).
* At least 4 years of experience in a biopharmaceutical/vaccines environment.
* Knowledge of material management systems and experience with Single Use Technology.
* Experience in manufacturing with a problem-solving approach, preferably in Vaccine Drug Substance.
* Strong technical and process knowledge in drug substance processing, including UF/DF, Lyophilisation, Bottle filling, PAT, and Single Use Technology.
* Excellent collaboration and project management skills.
* Knowledge of FDA/HPRA regulations and standards relevant to biopharmaceuticals and vaccines.
* Proven success in cross-functional teams and technical problem-solving.
* Stakeholder management skills across multiple decision-makers and teams.
* Ability to work independently with minimal guidance.
* Ability to forecast and monitor costs related to material consumption.
Additional Details
* Seniority level: Entry level
* Employment type: Contract
* Job function: Manufacturing
* Industries: Pharmaceutical Manufacturing
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