Job description
Technical Support Analyst
Your New Role
Key Responsibilities:
Provide Technical Leadership within the Drug Product manufacturing team including areas such as Formulation, Filling, Lyophilisation, Capping and Automated Visual Inspection.
Execution of equipment qualification deliverables during execution of project phase including equipment Commissioning & Qualification, IOQ.
Coordinate technical deliverables within Drug Product to support the successful product launch.
Provide technical support to the operations team’s during commercial manufacturing.
Lead/participate in manufacturing investigations with cross-functional teams to ensure that detailed root cause analysis is completed and appropriate CAPAs are implemented.
Support Batch Disposition activities by providing SME technical support for comment resolution.
Identify and implement projects to continuously improve the compliance and manufacturing capabilities within the Drug Product
Support continuous process and quality improvements through the deployment of Lean Six Sigma tools.
Creation and revision of technical documents including manufacturing batch records, SOPs, and technical memos.
In partnership with the site MS&T scientist the Principal Technical Support Specialist will provide comprehensive technical leadership to the DP organization.
Participate in Regulatory, Client and Internal audits inspections as the technical representative.
Delegate for Manufacturing Technical Lead.
What You Need:
Minimum 5 years working in biological, vaccine or pharma facility. Preferred candidate will have cGMP with biological, vaccine or pharma facility with prior sterile manufacturing experience.
Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
Ability to operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches.
Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g., Six Sigma
Experience in leading & resolving complex technical investigations
Experience in a risk-based approach to manufacturing through use of tools such as FMEA
Ability to adapt to changing priorities as project demands change
If you are interested in this role, please send your CV in Word format to Brenda.
Full detailed job spec available on request.
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