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Manufacturing Process Manager
2 months ago
We are seeking a highly skilled and experienced Technical Operations Manager to join our team at Thermo Fisher Scientific. As a key member of our Process Engineering team, you will be responsible for leading the development and implementation of manufacturing processes and technologies, ensuring compliance with Good Manufacturing Practices (GMP) and regulatory requirements.
Key Responsibilities- Mentorship and Leadership: Provide technical guidance and mentorship to the Process Engineering team, fostering a culture of continuous learning and improvement.
- Project Management: Lead the execution of projects for products transitioning into commercial production, ensuring timely and successful implementation.
- Process Development: Develop and propose process trains for new products, ensuring compliance with GMP and regulatory requirements.
- Quality Assurance: Collaborate with the Quality organization to support conclusions and resolutions related to deviations, investigations, audits, and Corrective Action Preventative Actions (CAPA).
- Technical Support: Provide technical assistance and support to the Operations team, ensuring smooth execution of trial, feasibility, and pre-commercial batches.
- Capacity Planning: Develop and implement continuous improvement plans for capacity, processes, and technologies, ensuring efficient operation of the function.
- Client Interaction: Lead client interactions during validation observation visits, promoting a positive and professional image of Thermo Fisher Scientific.
- Staff Management: Select, develop, and evaluate staff to ensure the efficient operation of the function, working with and advising staff on administrative policies and procedures.
- Education: College/Technical School diploma in a related technical field, with a Bachelor's degree in engineering, science, or a related field preferred.
- Experience: Minimum 7 years' experience in manufacturing, quality, technology transfer, or a relevant contract manufacturing cGMP regulated environment, with a minimum of 3 years' supervisory experience.
- Skills: Strong knowledge and understanding of manufacturing/operational processes, excellent interpersonal and communication skills, and the ability to motivate and influence.
- Compliance: Follow all Environmental Health & Safety Policies and Procedures, and work collaboratively with fellow team members to meet project and departmental objectives.
- Quality: Carry out all duties within strict compliance to quality systems SOP's and Good Manufacturing Practice (GMP), and maintain a clean and orderly workspace.
- Continuous Improvement: Proactively identify areas for improvement in the execution of procedures, and communicate risks to timelines in a proactive manner.