Bioprocess Specialist required for a pharma
Bioprocess Specialist required for a global biotechnology manufacture based in Cork. In this role you will support the manufacturing environment to ensure continuous support across investigations, change controls, validation etc.
You will have at least 2 - 3 years' experience in a similar role within a biologic GMP environment with direct experience in Cell Culture and/or Purification.
Main areas of responsibility:
- You will ensure master batch records, SOPs, training records and other documents are current and compliant under cGMP conditions
- You will own, investigate, write and approve associated deviations as well as support & coach Biotechnicians in these functions
- You will ensure areas meet compliance standards and audit areas against standards
- Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.
- Partner with validation subject matter experts, prepare/approve validation protocols, validation plans, protocol executions, and summary reports in support of ongoing revalidation and validation efforts required for commercial manufacturing.
- Develop, define scope and support the implementation of technical solutions under the guidance of site change control systems
- Effectively and consistently prioritize and delegate daily assignments and projects to technicians and associates. Ensure that all staff understand, properly prioritize, and execute their assignments and adhere to production schedule.
- Supervise, and perform as needed, employee training in Manufacturing Support, Downstream and Cell Culture operations
Education & Experience
- Bachelor's degree in biotechnology, chemical or biochemical engineering, biochemistry or bio-systems engineering or related field or equivalent experience.
- Minimum 2 - 3 years in a similar role
- Must have experience working with Cell Culture or Purification.
- Demonstrated experience working with NPI processes in production.
- Demonstrated ability to train and coach colleagues in processing, operational excellence, team interactions and delivering results.
- Experience with regulatory inspections.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.