Senior Engineering Documentation System Specialist

Organization: 
Bayer
Job Location: 
Berkeley, CA
Job Description: 

Bayer HealthCare (BHC) makes an important contribution to human and animal health with its innovative products and by researching new therapeutic approaches promoting science for a better life throughout everything that we do. Our Specialty Pharmaceutical business ranks among the top 10 specialty pharmaceutical companies worldwide. Our global research and development is focused in five distinct areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Specialized Therapeutics, and Women's Healthcare. As a specialty pharmaceuticals company, we focus our efforts in areas of high unmet medical need and where we can have the most impact. Our Medical Care division consists of Diabetes Care and Radiology and Interventional. The Diabetes Care division is one of the largest blood glucose monitoring businesses in the world, supporting customers in 100 countries. Radiology and Interventional is the world's leading supplier of contrast agents and injection systems for diagnostic and therapeutic medical procedures. The business also supplies mechanical systems for removing thrombi from blood vessels. Our Consumer Care business is a top competitor in many important product categories including analgesics, cough and cold, and nutritionals. More than 3,000 employees support 14 manufacturing sites in 11 countries dedicated to ensuring the delivery of a secure, high-quality, cost-effective supply of our products around the world. Our Animal Health business in North America is dedicated to making the world a better place for our veterinary customers, their clients, and the animals we all hold dear.

Job description
This position will play a lead role in the Design and Implementation of our department’s ongoing strategy of combining realistic processes with new technologies for distributing and managing our Engineering Documentation. Our strategy encompasses integration to other departments and systems to provide smoother and more compliant
processes for facilities documentation from feasibility and design through validation and operations. They will also be responsible for the administration of these systems. The incumbent interfaces with Engineers, the Quality Unit and Project teams, both internal and external in executing their job. A high level of knowledge of Engineering documentation and MOC processes in the cGMP arena is required.
Candidate must be able to:
•Analyze a business process, identify gaps and gains and provide an electronic workflow/process solution that satisfies all regulatory and user requirements.
•They must completely understand the technical and software aspects of the system and be able to make knowledgeable decisions on feasibility of solutions.
•Troubleshoot and identify root cause of a system issue. Provide and implement adocumented long term solution as well as implementing any required short term adjustments.
• Provide timely system and user support.

Responsibilities:
•Work with Engineering Project Managers, Coordinators and external consultants to set up and support project work in EDMS.
•Develop business plans and strategies for improvement of the overall system by working with stakeholders and investigating new technologies.
•Development of User Requirements, functional specifications, and management of the execution of the final approved plan.
•Provide User and Technical support for EDMS.
•Identify and analyzes system issues and develops long term, consistent solutions.
•Analyze associated business processes and develops appropriate solutions in EDMS. This includes the requirements and design of a usable interface, the supporting configurations and all required documentation and training materials.
•Provide technical and procedural expertise for the business processes associated with operating the system.
•Organize and develops consistency to the existing data and content through generation of documented procedures.
•Directs and assists projects in executing bulk loading of documents, drawings and data to EDMS.
•Implement improvements and procedures related to the usage of computer aided tools (CADD both 2D and 3D) and their integration to EDMS to improve quality of work and cost effectiveness.
•Work on assignments that are complex in nature where considerable judgment and initiative are required in resolving problems and making recommendations. May determine methods and procedures on new assignments and may provide guidance to other support personnel.

Requirements:
Your qualifications The selected candidate is required to possess the following:
• B.S. in Computer Sciences, Engineering or other applicable B.S. discipline
• Specific training and certificates in Document Management systems
• Minimum Experience:
• BS 6+ years
• MS 0 - 4+ years
Or an equivalent combination of education and experience.
•5-8 years of experience working with and administering Document Management systems.
•4 years working with Autocad software.
•3-5 years working with engineering documents/drawings in a GMP change controlled environment.
•Experience and knowledge of the processes and Change Management associated with Engineering Projects in a cGMP environment.
•Training and experience with Documentum fundamentals and Administration.
•Successful completion of Administrator training for McLaren software.
•Knowledge of databases and query languages.
Your application We offer a wide variety of competitive compensation and benefit programs. In addition to a competitive base salary, you will be eligible for an array of innovative rewards and recognition programs, variable pay and incentive opportunities as well as benefits
coverage beginning on your first day of employment. We are committed to helping our employees maintain a healthy balance between their responsibilities at work and home. You will be eligible for paid time off programs, paid company holidays, flexible work options and
numerous site conveniences. We are also committed to supporting your professional development through career ladders, training programs, tuition assistance and professional association events.

If you meet the requirements of this unique opportunity, we encourage you to explore how you can make a difference at Bayer by applying now.
To all recruitment agencies: Bayer does not accept unsolicited third party resumes.