Teva Biopharmaceuticals, USA (TBU) is responsible for developing innovative and biobetter biologics for Teva Pharmaceuticals - the largest generics company in the world. Located in West Chester, PA the staff of 100 specializes in biologics CMC and bioanalytical development. We have a range of products in various stages of clinical development from IND through BLA filing including, innovative mAbs, extended half-life biobetters and biosimilar products. TBU combines the financial stability of a large company with a small-company mentality emphasizing scientific-rigor and creativity within a Product Development context. Teva Biopharmaceuticals, USA (TBU) has an excellent opportunity for Sr. Manager of Automation & Technologies Engineering.
The candidate is responsible for actively coordinating and overseeing the selection, development, implementation, maintenance and administration of all biologics non-business systems and taking ownership of day-to-day technical support for network infrastructure, internal non-business desktop systems software and hardware. In addition, they will be responsible for the project management of new software and computers for the equipment used and purchased with in the biologics division along with the management and direction of the Automation Engineers with in the biologics operations support services organization. This position will become the liaison between Biologics and the Global IT team and will be the primary contact for all of biologics for non-business computerized systems questions, purchases and projects.
Develop, review and maintain organizational standards and strategies for hardware, operating systems, databases and software applications for all of biologics
Formalize policies, procedures and documentation of all technology systems
Apply GMP principles within the workplace. Incorporate cGMP and regulatory compliance into all assigned project scopes, design and construction activities
Become the liaison between Operations and Global IT groups as a cross functional team member to meet the biologics division’s project objectives
Provide moderate to advance technical assistance to site operating groups through investigations, control system assessments, and design support
Work directly with server/infrastructure to resolve difficult problems including LAN, WAN and special application issues
Assist in preparation and execution of the Validation Qualification protocols related to automated and control systems. Provides technical and non-technical feedback to validation personnel for the successful qualification of systems
Perform installation, configuration and upgrades of the Biologics Operations Support Services organization equipment.
Ensure efficient performance of software and computers for the equipment supported by the
Biologics Operations Support Services organization (PAS/UAS/PI/LIMS/EMS/EMPOWER)
Help to troubleshoot and diagnose Control system complex problems, working closely with Control System/Instrumentation Technicians and maintenance personnel
Update and develop User Requirement Specifications, Functional Specifications, Design Specifications, Operation and Maintenance Manuals for the new and existing control systems for all of the biologics division
Provide responsive, timely support to all end-user questions and support requests.
Responsible for adhering to company established security procedures
Responsible for all automation and lab peripheral equipment and its proper maintenance, including printers
LIMS and PI system configuration and administration support
Desktop support of all non-business systems computers for the equipment supported by the Biologics Operations Support Services Organization