Job Description
Organon is hiring a Technical Operations Lead to join our world class manufacturing site in Cramlington, Northumberland. In this role, you will provide technical leadership for the technology transfer and commercial manufacture of Oral Solid Dosage (OSD) bi-layer film coated tablets.
Role Responsibilities:
1. Develop and lead strategies for process and cleaning validation, provide technical manufacturing assistance with the preparation of validation protocols and oversee execution.
2. Provide technical oversight and support for associated processes including change control, Master formulae and recipes.
3. Develop and maintain appropriate process monitoring and control systems and oversee formal process reviews and investigations.
4. Investigate and follow up issues arising from manufacturing or laboratory deviations, establishing assignable causes for atypical processing events and implementing appropriate actions to improve process capability.
5. Ensure effective knowledge management for the product and manufacture process.
6. Apply appropriate tools to ensure effective control, visualisation and delivery of activities for example project management.
7. Management and leadership of nominated cross-functional teams and specialist tasks.
8. Management of personnel within the performance management system, including coaching and mentoring.
9. Ensure compliance and provide support to systems including Quality, Safety, Environmental and Finance.
Qualifications and Experience:
1. Demonstrable experience in pharmaceutical manufacturing within a process support environment.
2. Strong knowledge of OSD processes and bi-layer tableting.
3. Degree in Science or Engineering, or equivalent.
4. Excellent technical communication and influencing skills.
5. Effective cross-functional communication and collaboration.
6. Project management skills in a lean manufacturing environment.
7. Proven ability to anticipate and solve problems, managing multiple priorities and monitor execution to plan.
8. Proven ability to develop and maintain successful business relationships with partners.
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