Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

Roche in 50 words: A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.

The Opportunity:

• Oversees work groups which conduct equipmentand Facility validation, planning and logistics and other routine activities. Is responsible for the accuracy, quality and timeliness of logistics activities and equipment and facility validation activities.

• Performs and manages the qualification Process Control Systems

• Performs and manages the qualification of utility systems (processed water, clean steam and compressed dry air)

• Performs and manages the qualification of environmentally controlled manufacturing areas.

• Provides developmental plans for direct reports and conducts on-going performance management activities.

• Ensures that work group performs work according to established internal safety guidelines and procedures, and as specified by appropriate external regulatory agencies (e.g., OSHA, FDA, ISO).

• Serves as a technical resource and mentor to the members of the work group and resolves issues encountered in the logistics and planning processes to improve performance. Provides definition and plans for timely achievement of overall product or project goals and to the expeditious transfer of technologies.

• Analyzes complex data using the required system and various data analysis software. Leads investigations, validation deviations and forms conclusions and makes recommendations, provides or implements process improvements and document improvements. Prepares complex reports, presentations, protocols and other documents. Review and approve protocols, final reports and other documents associated with equipment and facility validation.

• Documents validation/qualification and logistics activities accurately and appropriately, and according to established formats. Writes and/or revises documents (e.g., SOPs, Variances, Change Requests) timely and in compliance with cGMP/ QSR practices.

• Supervises day-to-day operations and three to four staff, coordinating the scheduling and execution of planning and logistics procedures. Defines and monitors project timelines, ensuring timely achievement of overall project goals and establishing priorities. Performs supervisory functions including performance management and career development guidance for direct reports. Responsible for providing appropriate training and development opportunities for staff.

• Participates in managing the schedule and work assignments for planning and scheduling projects and operations information management. Participates in or leads project-based activities (ex: equipment qualification and facility validation ) to support departmental goals. Maintains control of work group expenses within limits of DOA.

Who You Are:

• Bachelors in Engineering, Biological Science, Chemistry, Biochemistry or related field Plus 8 years relevant industry experience or Equivalent combination of education and work experience.

• Experience in qualification/validation of process equipment, analytical equipment, process control systems (PCS), utility systems (processed water, clean steam and compressed dry air), and environmentally controlled facility validation, data analysis, and data and concept presentation. Knowledge of regulations by FDA and other regulatory bodies. Experience in quality systems regulations and people management.

Relocation is not available for this role

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 is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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