Job Detail

Job Description

• Manage a wide variety of compliance oversight activities expanding several quality subsystems to ensure the safety, efficacy and purity of the products manufactured by Biogen.


• Support execution of the strategy of the commissioning and qualification activities to bring the facility to operational readiness and expands its future capacity.


• Design, manage and develop the Solothurn QE Team of subject matter experts who themselves are responsible for specific functions according to job descriptions.


• Review and approve GMP documentation (plans, protocols, procedures, CAPAs, deviations, etc.) specifically related engineering, facilities and the BES


• Ensure adherence to internal procedures for facility/equipment and automation controls and release before, during and after production operations (i.e. routine operations, shutdowns, construction projects, product changeover)


• Represent Solothurn Quality Engineering within the Global Quality Organization. 

Qualifications

• Bachlor’s degree in relevant field such as Chemical Engineering, Mechanical Engineering, Bio-Engineering, Automation Systems


• 8+ years of experience in pharmaceutical or biotech manufacturing environment. Experience with automated operations, projects and management, Quality Assurance, Validation, Automation/MES or related function is preferred.


• Must have proficiencies with the Quality systems and, preferably, with business processes associated with automation and integration of testing and production systems. 


• Demonstrated ability to work autonomously and to lead project teams in a matrix organization.


• Strong oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectively


• Strong presentation and organizational skills


• Demonstrated problem solving skills


• Must have strong technical skills and be proficient with typical productivity software (Word, Excel, PowerPoint, Visio, etc.)


• Experience in drug substance (or API) and drug product are preferred


• Travel up to 50% to other sites. 

Additional Information

The Senior Manager of Quality Engineering is mainly responsible for operational oversight of a Quality Engineering group at the new Large-Scale Manufacturing facility located at the Solothurn/Switzerland site. He is responsible for the Quality Oversight of the manufacturing facilities, engineering and utilities activities and local Biogen Execution Systems (BES) e.g. Delta V, Syncade, Simca, Infobatch, SyntQ and PLC driven equipment. The Solothurn site is intended to operate with a fully integrated electronic batch record.

The holder of this position will be responsible for the following activities:

• Oversight of the local Quality Systems especially related to utilities, engineering, facilities and the BES.


• Ensure Equipment, utilities and facility design, build and qualification is successfully done according to current GMP and regulatory policies.


• Review and approval of Qualification, Validation and Engineering documents during both project and operational phases of the site.


• Involvement in validation and change control of the BES systems being implemented and operated at the Solothurn site.


• Review of GMP documentation and data for compliance to applicable procedures, regulatory and/or corporate guidance documents.


• Responsible for QA activities (Deviations, test protocols, change control and CAPAs) associated to equipment and automation systems in scope.


• Act as a main point of contact Quality Engineering topics (internal and external to the Solothurn site). These topics might be cross-functional in nature and may involve participation across sites as well.


• Provide leadership on global and site cross-functional teams

The Senior Manager of Quality Engineering will lead a team of associates, which includes responsibility for scheduling and balancing of departmental workload, interviewing, hiring, training, developing and mentoring of subordinate employees. As appropriate, the Senior Manager of Quality Engineering, may also be called on to perform job functions delegated by Associate Director of Quality Engineering of the Solothurn site. These delegated responsibilities may include, but are not limited to, providing QA approval of major/critical planned exceptions or deviations, and approving deviation status updates.