An amazing opportunity has arisen for a Shift Engineer/Technical Lead. The Shift Engineer/Technical Lead provides technical expertise to the manufacturing shift team in support of the drug substance production. Work with the manufacturing shift team to ensure the effective and efficient on-time delivery of batch production. This requires the delivery of process excellence and reliability across all areas of the manufacturing process.
This role is site-based and shift-based.
What You Will Do
Bring energy, knowledge, innovation and leadership to carry out the following:
1. Support the manufacturing team to consistently deliver on specific Key Performance Indicators (KPIs), e.g. EHS metrics, Production Plan, right first-time execution, compliance and team training.
2. Provide technical expertise in establishing the commercial process and routine manufacturing operations by serving as a commercial manufacturing process subject matter expert.
3. Create and sustain a culture of right first time in safety, quality and continuous improvement through a focus on principles of lean including simplification, standard work, visual management and learning development.
4. Ensure highest Quality & Compliance standards.
5. Subject matter expert for troubleshooting process issues during tech transfer activities and commercial operations.
6. Responsible for driving a culture of Continuous Improvement by deploying Six Sigma tools within the IPT on projects such as: problem solving, reducing cycle time, lean principles within the process.
7. Coach manufacturing personnel to increase technical knowledge of critical process steps on the floor.
8. Write, review, and/or approve manufacturing documentation (SOPs, Manufacturing Records & Logbooks) ensuring it is current, accurate and in accordance with regulatory requirements.
9. Lead complex process investigations on the production floor in support of deviation resolution.
10. Provide ongoing coaching and support to cross-functional team members, to share manufacturing best practices.
11. Track and trend relevant technical and business process metrics to ensure operations are performing effectively and efficiently.
12. Ensure the effective use of material, equipment and personnel in producing quality products.
13. Participate in safety, process and environmental investigations. Review alert and action limits as needed and implement corrective action as appropriate.
14. Get actively involved by participating in inspections, GEMBA’s and Go-See’s.
General Competencies
What skills you will need:
* Excellent communication, decision making, people influencing and project management skills.
* Excellent focus and attention to detail.
* Demonstrated problem solving capabilities.
* Ability to work independently and as part of a cross-functional collaborative team to achieve mutual goals.
Technical Competencies
* Thorough knowledge of current Good Manufacturing Practices (cGMP).
* In-depth working knowledge of manufacturing operations.
* Ability to read, write and understand technical information.
Minimum Education/Experience
* Degree in Science, Engineering or other technical discipline.
* 5 years experience in a large-scale biologics manufacturing facility, including a technical or manufacturing support role.
As a company, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
So, If You Are Ready To
Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.
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