Technical Support Specialist

4 weeks ago

Dundalk, United States WuXi Biologics Full time

Career Opportunities: Technical Support Specialist (Drug Product) (4098)

Requisition ID

4098

- Posted -

Dundalk, IRL

-

Ireland Provide Technical support 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 MFS, engineering batches and 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 REQUIREMENTS Minimum 2 years working in a cGMP biological or vaccine facility (process development).

Preferred candidate will have cGMP experience with biological, vaccine or pharma facility with prior aseptic manufacturing experience Ability to operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches Experience with AVI/MVI and creation of library of defects will be advantageous 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 EDUCATION Engineering or Science Degree or related discipline OTHER SKILLS, ABILITIES & EXPERIENCE Ability to explain complex technical issues to external customers / agencies Experience with the use of single use technology in DP Manufacturing Experience in aseptic techniques Demonstrated excellence in planning and organizational skills Demonstrated skills in communication (oral and written) & in particular technical writing

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