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Director at R.T.Lane Recruitment 022 46969 or 087 9669394 rachel@rtlanerecruitment.ie
New Role: Contract Technical Operations Specialist with experience in Drug Substance and Vaccine manufacturing.
Site based role in Cork.
Please reach out today for more details: 087 9669394 rachel@rtlanerecruitment.ie
* Support department and site level activities requiring process and operational knowledge.
* Support process operations, troubleshoot technical and process-related issues, and lead investigations using MPS principles such as DMAIC, A3, OPPS, etc.
* Manage EHS and Quality investigations, coach staff, complete and oversee batch record reviews.
* Lead cross-functional technical projects to further develop the vaccine process.
* Support and manage process robustness changes and product introductions.
* Lead cross-functional project teams for troubleshooting and investigations within Vaccines IPT and across the site.
* Provide high-level process knowledge to supporting functions and projects.
* Support material management and troubleshooting with a focus on cost.
* Apply Lean Six Sigma and Lean methodologies.
* Represent the department on cross-functional project teams.
* Adhere to the highest standards for compliance: safety, quality, and cost.
Required skills:
Likely candidates will have:
* Honours Degree or Masters in Science or Engineering (preferably Biotechnology).
* More than 4 years’ experience in a biopharmaceutical/vaccine environment.
* Knowledge of material management and related systems; experience with Single Use Technology including operational use, problem solving, and vendor engagement.
* Direct manufacturing experience with a problem-solving mindset, preferably in Vaccine Drug Substance.
* Strong technical and process knowledge in drug substance processing unit operations, including UF/DF, Lyophilisation, Bottle Filling, PAT, and Single Use Technology deployment.
* Strong collaboration and project management skills; ability to establish good relationships at all levels, resolve conflicts, and devise creative solutions.
* Knowledge of FDA/HPRA regulations and standards for quality and regulatory compliance in biopharmaceuticals/vaccines.
* Proven success in cross-functional teams, such as project teams.
* Ability to solve complex technical problems using existing solutions from new perspectives.
* Stakeholder management skills involving decision-makers, colleagues, and cross-functional teams.
* Ability to work independently with minimal guidance.
* Experience in forecasting, planning, and monitoring costs related to material consumption.
Seniority level
* Associate
Employment type
* Contract
Job function
* Engineering, Manufacturing, and Quality Assurance
Industries
* Pharmaceutical Manufacturing and Biotechnology Research
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