Teva Pharmaceuticals USA, Inc.

Senior Manager Automation & Technologies Engineering

US-PA-West Chester
Requisition #
17-20143
# Positions
1
Experience (Years)
8
Category
Engineering - Mechanical Engineering

Overview

 

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.

 

 

 

Responsibilities

Responsibilities

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

 

Qualifications

Requirements

  • Electrical/Controls or Computer Science Engineering Degree (BSEE or BSME)
  • 10 years hands on experience with systems, SQL relational database systems, and Networking including design and debugging skills. Hands on experience with Windows Servers hardware and Microsoft Windows - applications
  • 5 years of experience in pharmaceutical environment including regulatory requirements associated with 21 CFR Part 11 and supporting validation of control system equipment
  • Technical training in PLC / controller programming, Operator interface design, Robotics, PC programming, SQL database systems, historians, VBA, Microsoft OS management skills.
  • Proficiency in reading / making drawings or revisions (P&IDs, electrical schematics, and VBA)
  • Possesses a high level of technical expertise on a specific process control system and their connections to lab equipment, production equipment, instrumentation, and manufacturing systems
  • This position requires a high degree of analytical skills to provide automated solutions to improve processes and integrate new equipment to meet company and project objectives
  • Familiar with AutoCAD, Allen Bradley PLC programming software, SQL, WonderWare, Sci Pure and Unicorn SCADA software and various types of PLC and PC based software
  • Ability to organize and present technical and project mgt. overviews without assistance
  • Technically independent and maintains state-of-the-art technical abilities. Display initiative and commitment. Able to make independent contributions to the development of new methodologies or new technologies for process control systems. These activities are done under limited supervision
  • The position may require 5-10% travel for equipment FATs, system evaluations, and/or conferences or technical training

 

 

 

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