Focus Topic Lead - Cleanroom Classification and Qualification (d/m/w) - Engineering Science and Technology (ES&T) Kaiseraugst

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The Position

Who we are:

With its 1,400 employees, the Kaiseraugst production center (PT Manufacturing) ensures uninterrupted patient care with high-quality medicines. We stand for the highest standards of pharmaceutical manufacturing, Roche's largest, most innovative packaging center and serving more than 120 countries.

For a successful production site Kaiseraugst Engineering Science and Technology ( ES&T) advances and enables innovation and improvement by using science, technical knowledge and predictive services. Our key success factors for sustainable and compliant asset performance are continuous improvement of our processes, agile employees and passion

The Role:

As a focus topic lead for clean room classification and qualification you have the oversight over all activities necessary for clean room (re-)qualification, monitoring and trending in the production facilities in Kaiseraugst.  This includes the concept development and revision for non-viable particle measurement, but also for required (re-)qualification activities such as the determination of air exchange rate, recovery rate, clean-up period, airflow visualization and others. In particular, the requirements according to Eudralex GMP Annex 1 and the underlying ISO 14644 must be taken into account.

The concept for measuring non-viable particles should be closely linked to that for viable particles. It is the job of the post holder to drive forward the merging of the concepts.  In this context, the results of airflow visualizations must also be included. Cleanroom classification and the associated control mechanisms are an essential part of the Contamination Control Strategy. You will be responsible for maintaining and implementing the Contamination Control Strategy for the relevant topics.

Your area of ​​responsibilities:

• Ownership and end-to-end oversight of of the clean room classification and (re-)qualification concept with focus on total particles in Kaiseraugst 

• Oversight and prioritization of measurements and ensuring their quality

• First contact point for new projects such as clean room classifications/requalifications and Doc SPOC for the global community

• Strategic conception, promotion and implementation of optimizations in close cooperation with partners in ES&T, the value streams and QA at the site Kaiseraugst as well as with strategic partners (e.g. PTQ) in the network

• Promote harmonizations (e.g. regarding the overall concept and its implementation, especially with a focus on a closer connect of concepts for viable and non-viable particles) across all production units within Kaiseraugst

• With a focus on customer- and value-oriented work, you remove barriers and promote collaboration with key stakeholders as a matrix leader

• Creation/revising of Standard Operating Procedures (SOPs) and associated GMP documents

• Assessment and processing of changes, deviations as well as corrective and preventive measures

• Ensuring an excellent  flow of information

• Representation of the monitoring unit in health authority inspections and audits

• Willingness to work in a self-organized team with a high degree of personal responsibility in an open and collaborative environment

• Promoting methods and tools together with the LPS team and putting them into practice in day-to-day business. Introducing ideas to improve quality, plant efficiency, cost reduction and processes.

• Close cooperation with value streams,  internal and external interfaces to achieve ambitious goals for lead time, quality, commitment and costs.

• Following the SHE rules and ambitions (safety, health and environment) 

Competencies Identified for Success:

• An outcome-oriented and can-do attitude combined with a new way of thinking and mindset that serves as basis for the success of the organization

• Demonstrated experience and success with building networks and collaborating with key partners locally and globally.

• Strong understanding of the right to operate, governance, sustainability, and best practices in monitoring business operations supporting high performance culture.

• Pursue new bold concepts and challenging the status quo

• Passion to engage a team with strong problem solving skills

• You trust yourself and others, take responsibility and live an open speak-up and failure culture

Qualifications/Requirements:

• A master degree in pharmaceutical- or lifescience, chemistry or engineering or similar education level and minimum 5 years of professional experience in pharmaceutical production, monitoring or process development

• An entrepreneurial and systemic way of thinking with a view of the overall process (“end to end”) and the ability to consistently perform at a high level in a constantly changing environment.

• Good knowledge of relevant health authority requirements, strong experiences in representing in inspections and experiences in executing registration relevant technical changes

• Proven successful delivery of cross functional projects

• Ability to effectively communicate and influence others across all levels of the organization 

• Several years of experience in the field of microbiology/hygiene concept and a proven ability to reduce complexity

• A fundamental, working understanding of safety, quality systems, and quality assurance concepts are required including the application of current Good Manufacturing Practices (cGMPs)

• Track record of having the courage to drive change, while balancing risks and pacing for success

• Fluent verbal and written communication skills in German and English.

• Ideally experience in dealing with digitization of processes

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche Kaiseraugst is a cornerstone of Roche's global production and logistics network. It employs some 1900 people out of the 10,700 employees at our Basel/Kaiseraugst site and is Roche's largest and most innovative packaging facility worldwide. Read more.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.