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MST Engineer II
Holly Springs, NC 27540 United States
Are you looking for a rewarding career in a market-leading and innovative company?
Seqirus is the new global company created from the combined strength and expertise of bioCSL and the influenza vaccines business formerly owned by Novartis. In July 2015, bioCSL and the influenza vaccines of Novartis joined forces to create what is now the second largest influenza vaccine company in the world. With extensive research and production expertise and manufacturing plants in the US, UK, Germany and Australia, Seqirus is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
Currently for our Manufacturing Facility in Holly Springs we are looking for the MST Engineer II. The role will provide front line expertise for production process-specific issues to Manufacturing for multiple unit operations or processes, ensure on-time execution of processes, and continuous improvement in quality, yield and efficiency; performed in compliance to cGMP’s, SOPs, and applicable guidelines.
MST Engineer II
Technology Transfer / Clinical Trial Mfg / 3rd Party Management
• Support MS&T and Site Processes for the transfer of product/processes to Seqirus/CSL sites and CMO’s, as needed
Shop Floor Support:
• Provide front line support to Manufacturing, working with the shift teams, focusing on manufacturing each batch safely, on time, in compliance with the batch instructions and quality requirements.
• Monitor process data for trends, investigating and escalating issues.
Validation – execution and review of protocols/reports:
• Support the execution of process validations, annual monitoring batches, and short-term improvement projects, liaising with all the relevant parties at shop floor to ensure accurate execution
• Review that validation protocols and reports are technically correct
• Ensure protocols are executed as intended
Technical improvement execution:
• Execute process improvements, scale-up.
• Ensure that process technical batches generate sufficient process knowledge by thoroughly testing critical variables.
Assure consistency of Master Batch Records:
• Ensure that all critical and significant parameters are within written Instruction (i.e. Master Batch Record, Validation Plan), sufficient and appropriate for the product
Deviations and complaints:
• Lead root cause analysis for non-critical product and process related investigations and deviations including complaints, Out Of Expectation, Out Of Specification.
• Use scientific and statistical knowledge to analyze data to provide process understanding, and to identify root causes of product and process failures.
Annual Product Reviews and Product Quality Reviews:
• Contribute to Annual Product Reviews and Product Quality Review for analysis and for contributing to process technology innovations.
• Provide input to audits as appropriate, including Subject Matter Expert for audit topics
• Bachelor’s Degree in related scientific/engineering field with 5+ years related experience or Master’s Degree in related scientific/engineering field with 3+ years related experience
• Requires conceptual and practical experience with the project management function
• Ability to work with cross-functional teams and communicate effectively
• Must be highly skilled in Microsoft Word, Outlook, Excel and experienced with PC’s and databases
• Knowledge of Good Manufacturing Practices (GMPs) required
• Must have excellent communication skills and strict attention to detail
• Must be flexible, able to multi-task in a fast-paced environment, and operate well in a team setting
North Carolina Biotechnology Center