Principal Technical Support Specialist

Orion Group Life Sciences are currently recruiting a Principal Technical Support Specialist on behalf of our Multinational Biopharmaceutical Client based in Louth on an initial 11-Month contract with potential to extend.

REQUIREMENTS:

• 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.

REQUIREMENTS:

• 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.
• 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

EDUCATION:

Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.

OTHER SKILLS, ABILITIES & EXPERIENCE:

• Previous experience in an operations role within vaccine manufacturing preferred.
• Knowledge of USP1790 and industry/ regulatory requirements such as Annex 1 desirable
• Ability to explain complex technical issues to external customers / agencies
• Experience with lyophilized products advantageous
• Experience in start-up facility advantageous
• Demonstrated excellence in planning and organizational skills.
• Demonstrated skills in communication (oral and written) & in particular technical writing.

Our role in supporting diversity and inclusion

As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.