Technical Lead Clean Room
Il y a 6 mois
TECHNICAL LEAD CLEAN ROOM
- Biotech- GhentABOUT THE COMPANY
The Technical Lead for Clean Room Operations will play a critical role in ensuring seamless daily production tasks within Manufacturing Operations. This role involves building strong partnerships across various departments, including Quality Control, Quality Assurance, Facilities & Engineering, Manufacturing Science & Technology (MS&T), Training, Planning, and the Warehouse. The Technical Lead will serve as the first point of contact for technicians and experts on the production floor, addressing production issues and working as part of a cross-functional team.
**Key Responsibilities**:
**Quality Assurance Leadership**:
- Coordinate, manage, and control all quality aspects related to production activities and batch production in cGMP areas.
- Timely review of production documentation (procedures, work instructions, logbooks, transfer forms).
- Act as a backup for the Operations Supervisor in reviewing executed batch records (both paper and MES).
- Conduct routine and spot-check inspections on production documentation.
- Manage production-related QMS documentation (deviations, CAPA, SOPs, cleaning validation, protocols, and reports) in collaboration with MS&T and Quality.
- Review cGMP documents generated by Production before QA review.
- Support communication of KPIs related to quality aspects in Production.
- Act as the production SME for internal and external audits in collaboration with QA, escalating production-related matters to ensure timely decisions and follow-up.
**Production Process Expertise**:
- Provide guidance and perform production tasks in alignment with safety policies, quality systems, and cGMP requirements.
- Support Tech Transfer plans for new production introductions or process optimisations, including risk assessment, execution, and readiness for clinical and commercial phases.
- Participate in developing manufacturing processes and continuous improvement initiatives within cell therapy Technical Operations.
- Assist in the qualification/validation of new materials, consumables, and equipment.
- Support drug product investigations, including batch failures.
- Participate in training sessions for various manufacturing processes.
- Communicate KPIs related to production output.
**Operational Management**:
- Attend and lead (in absence of the Ops Supervisor) daily start-of-shift and wrap-up production meetings.
- Assign daily production tasks and ensure their successful completion.
- Organize training sessions in collaboration with the Training team and Operations Supervisor.
- Collaborate with the Operations Supervisor and Manager to oversee the development of production personnel and provide performance feedback.
- Support quality and EHS risk assessments for production activities, zones, equipment, materials, and data.
- Assist in the design, specification, construction, qualification, validation, and regulatory approval of production capabilities.
- Identify issues and drive continuous improvement initiatives for production operations.
- Manage inventory and ensure material availability in production zones.
- Monitor production areas in collaboration with Maintenance/Engineering, QC, and Facility teams.
- Ensure safe and compliant manufacturing operations per EHS and cGMP procedures.
- Work collaboratively and flexibly within the team.
REQUIRED COMPETENCES & SKILLS
**Education**:
- Bachelor’s or Master’s degree in Science, Bio-Engineering, Pharmacy, or related field, or equivalent experience.
**Experience**:
- Minimum 2 years in operations within a cGMP or ATMP environment in biotech/pharma.
- At least 2 years of aseptic/grade C GMP manufacturing experience.
- At least 1 year of team or project leadership experience.
**Capabilities, Knowledge, and Skills**:
- In-depth knowledge of cGMP regulations and EMEA guidance for cell-based products and cleanroom behaviors.
- Strong leadership and communication skills to effectively influence and guide team members.
- Ability to work independently, prioritize, and manage multiple tasks in a fast-paced environment.
- Strong organizational skills and ability to manage shifting priorities.
- Excellent analytical, problem-solving, and critical thinking skills.
- Proactive, hands-on approach with a can-do attitude.
- Tenacity to resolve issues and deliver results.
- Enthusiastic team player with a flexible mindset.
- Clear verbal and written communication skills with attention to detail.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
- Experience with MES/EBR is a plus.
- Ability to work shifts, including evenings and weekends, and accommodate unplanned overtime.
**Requirements**:
- Shift work: Early, Late, and frequent weekends. More details will be provided during the initial contact.
**Languages**:
- English/Dutch
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