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Recruitment Director - Contracting Solutions at HRM Search Partners
A leading global animal health business dedicated to innovation are expanding their operation in the midlands. The organisation delivers quality medicines and vaccines, complemented by diagnostic products and genetic testing for their customers.
A new position has become available for an experienced Process Scientist to join this dynamic team on their biologics site in the Midlands. This role is within the Manufacturing & Technology Department and reports into the Senior Manager of Manufacturing Technology.
The Position
* Support new product introductions, technology transfers, process validation activities, and the preparation of CMC documentation for regulatory filings.
* Provide "hands-on" technical support for manufacturing process activities and support team input to investigations and resolution of process deviations, root cause analysis, CAPAs, process improvements, change controls, and preparation of regulatory filings.
* Accountable for delivery of upstream and downstream technical documents, including protocols, reports and SOP's supporting the validation of the manufacturing process. Assist in evaluating process performance by comparing manufacturing data to historical data.
* Strong knowledge of cGMP compliance, site and regulatory agency requirements, and provide process subject matter expertise for regulatory inspections and other interactions with regulatory agencies.
* Participate in continuous improvement initiatives, action plans to implement operational excellence, and lean practices along with setting and maintaining department goals and metrics.
The Person
* Educated with a BSc, MSc, PhD in a relevant discipline (e.g. Biochemistry, Chemistry, Process Engineering).
* At least 3 years' relevant experience in bioprocess development with project exposure to new product introductions or tech-transfers.
* Proven experience supporting large-scale manufacturing operations, upstream & downstream processing as well as cGMP and US/EU regulations.
* Knowledge of quality systems (ETS, SAP, Veeva Vault), Quality by Design, validation principles for product and manufacturing processes, engineering design and process control fundamentals in commercial manufacturing.
To discover more about this opportunity, apply now or contact Aisling Clements at HRM on +353 87 7521041 for a confidential discussion.
A leading global animal health business dedicated to innovation are expanding their operation in the midlands. The organisation delivers quality medicines and vaccines, complemented by diagnostic products and genetic testing for their customers.
A new position has become available for an experienced Process Scientist to join this dynamic team on their biologics site in the Midlands. This role is within the Manufacturing & Technology Department and reports into the Senior Manager of Manufacturing Technology.
The Position
* Support new product introductions, technology transfers, process validation activities, and the preparation of CMC documentation for regulatory filings.
* Provide "hands-on" technical support for manufacturing process activities and support team input to investigations and resolution of process deviations, root cause analysis, CAPAs, process improvements, change controls, and preparation of regulatory filings.
* Accountable for delivery of upstream and downstream technical documents, including protocols, reports and SOP's supporting the validation of the manufacturing process. Assist in evaluating process performance by comparing manufacturing data to historical data.
* Strong knowledge of cGMP compliance, site and regulatory agency requirements, and provide process subject matter expertise for regulatory inspections and other interactions with regulatory agencies.
* Participate in continuous improvement initiatives, action plans to implement operational excellence, and lean practices along with setting and maintaining department goals and metrics.
The Person
* Educated with a BSc, MSc, PhD in a relevant discipline (e.g. Biochemistry, Chemistry, Process Engineering).
* At least 3 years' relevant experience in bioprocess development with project exposure to new product introductions or tech-transfers.
* Proven experience supporting large-scale manufacturing operations, upstream & downstream processing as well as cGMP and US/EU regulations.
* Knowledge of quality systems (ETS, SAP, Veeva Vault), Quality by Design, validation principles for product and manufacturing processes, engineering design and process control fundamentals in commercial manufacturing.
To discover more about this opportunity, apply now or contact Aisling Clements at HRM on +353 87 7521041 for a confidential discussion.
Desired Skills and Experience
PROCESS SCIENTIST, PROCESS ENGINEER, MSAT Specialist, NPI Engineer, NPI Scientist, MSAT Scientist
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Job function
Manufacturing and Science
* Industries
Pharmaceutical Manufacturing
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