Senior Operations Process Specialist

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Senior Operations Process Specialist (m/f)

The Senior Operations Specialist supports the CM&T Operations organization and the Facility StartUp Manager. The role is responsible for executing nonconformity (NC) and NC/CAPA processes and for supporting F2P2 Next Level startup activities. It also provides operational support for new technology implementations continuous improvement initiatives and productportfolio projects to enable compliant scalable clinical manufacturing operations.

Main responsibilities include the following:

• Lead investigations into nonconformities drive corrective and preventive actions (CAPAs) and verify closure in collaboration with Quality.

• Provide operational and technical input and handson assistance for commissioning qualification and GMPcompliant operations.

• Support technical assessments and pilot testing contribute to process validation and SOP/workinstruction development and help ensure readiness for transfer to operations.

• Collaborate with Quality Engineering Project Management and other local functions to resolve startup and rampup issues and mitigate operational risks.

• Support generation and improvement of required GMP documentation

• Support the technical implementation of New Product Introductions (NPI) in for successful aseptic process simulation (APS) with hand-over to operational team

For this position we are looking for an experienced professional with working experience in a highly regulated environment (FDA/J&J standards and guidelines general GMP guidelines) project management effective communication leadership and excellent interpersonal skills to build a reliable network within a matrix organization.

The following hard skills are required:

• Completed vocational training in the pharmaceutical field or a BSc in Pharmaceutical Biochemical Chemical or related Sciences.

• At least 5-7 years of professional experience in related activities in the pharmaceutical industry

• Excellent technical understanding of aseptic manufacturing technologies and processes

• Production experience within a GMP regulated environment is mandatory

• Strong knowledge of Annex 1 requirements and contamination control principles in aseptic manufacturing environments.

• Excellent interpersonal skills

• Change management skills

• Project leadership experience

• Excellent analytical skills communication strength empathy assertiveness and high customer and business orientation.

• Very good level of German and English both spoken and written.

• Experience supporting facility start-up operational readiness technology transfer and qualification activities is highly desirable.

We are offering you a multifaceted challenge in a dynamic international environment with high technology standards attractive terms and excellent infrastructure.

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If you are interested in this position then please apply online including application letter CV and ideally testimonials.

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