Job Description
Organon is hiring a Senior Process Engineer/Scientist to join our world-class manufacturing site in Cramlington, Northumberland. In this role, you will be responsible for the management and execution of Technical Operations projects which can include technical transfers, new equipment, supplier item qualification, cleaning, and continuous improvement initiatives.
The successful candidate will provide leadership, governance, and technical expertise to ensure that projects or activities impacting Technical Operations are delivered safely, compliantly, and in line with required timelines and budget.
Role Responsibilities:
* Lead technical projects and provide technical expertise for all processes involved in the manufacturing and packaging of products on site, including technical transfers, assistance with specification, testing, qualification, and operation of new capital process equipment.
* Manage complex investigations and follow up issues arising from manufacturing, packaging, or laboratory deviations, establishing assignable causes for atypical processing events and propose appropriate actions to minimize rework and improve process capability.
* Develop strategies for process and cleaning validation activities on site, provide technical manufacturing assistance with the preparation of validation protocols and oversee in-process validation sampling.
* Lead site compliance with the standards in policies, procedures, guidelines, and SOPs and comment/author as appropriate.
* Coordinates/Mentors/Implements training of other members of the Technical Services group and educating other areas on the roles and responsibilities of Technical Services.
* Lead Operational Excellence activities – continuous improvement, systems robustness with the use of appropriate LSS tools and innovative mindset.
Qualifications, Skills and Experience:
* Demonstrable experience in Pharmaceutical manufacturing, preferably in a process support environment.
* Degree in Science or Engineering Discipline or equivalent.
* Proven ability to communicate, influence and work effectively in both individual and cross-functional environments.
* Effective time management and organization skills to aid prioritization, resource allocation, and meet project deadlines.
* Proven logical, analytical approach to problem-solving with high complexity with good root cause analysis to develop new systems and ways of working, utilizing Lean Six Sigma principles.
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