Job Description

The role of the Technical Coordinator is to provide technical and validation expertise in support of continuous improvement efforts including gaps assessments, CAPAs and project remediation activities. The Technical Coordinator will contribute to maintain compliance with all cGMP regulatory standards.

The Material Technology and Lifecycle Management team within the Centre of Expertise (CoE) leads the validation activities and technical activities related to Critical Materials Management (CMM), raw materials, filters, single-use systems, and extractables & leachables (E&L).

Education/Certifications

• BS (Science/Engineering) or MS (Science/Engineering) with 3 to 5 years of related experience in biotech pharma/biotech manufacturing, and quality environments

Competencies:

• Strong technical writing is essential

• Proficient with MS Visio for creation of Single-use prototype Designs and Process Flow Diagrams

• Demonstrated understanding of current Good Manufacturing Practices, Health and Safety, high quality standards, industry standards and their application to the manufacturing process

• Equipment validation experience is an asset

• Expertise in process industrialization with practical experience in industrial manufacturing environment

• Good understanding of current regulatory requirements and document preparation

• Effective in troubleshooting and root cause analysis

Description of Activities

1. Author and review filter validation protocols and reports

2. Author and review material specifications, user requirement specifications and support with Quality Technical Questionnaires

3. On behalf of Mtech, manage investigations related to filters SUS and relevant validation studies within the legacy industrial space and capital projects

4. Contribute to the site Critical Materials Management (CMM) project by creating change control plans, define critical material attributes and key material attributes (CMA/ KMA), support the regulatory submission documentation

5. Design and manage validation studies to support process improvement initiatives and CAPAs

Key accountabilities

1. Ensure robustness and continuous improvement of manufacturing processes. Strengthen process and product knowledge through process criticality analysis, presence at the shop floor and technical assistance to current manufacturing processes. Stay abreast of current advances in area of technical expertise

2. Drive troubleshooting/investigation related to his/her products/process. Supports the manufacturing areas with complex issues, product impact assessment, and root cause analysis

3. Contribute to strategy related to specific project, process validation, scientific and technological assessment and inspection readiness. Drive the implementation of actions plans

4. Generate and drive CCRs to implement material or process changes. Generate and drive CAPAs to implement corrective or process improvement initiatives

5. Contribute on Project Teams, as MTech representative. Interface with other MTech areas and other departments (e.g. Vaccine Industrial Affairs (Bulk Manufacturing), QO Validation, QO Shop Floor, QC, GEM, R&D, RA) for assistance

6. Contribute to maintain compliance with all cGMP regulatory standards, policies and procedures

7. Participate in regular staff and technical meetings, and maintain open lines of communication

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