Senior Validation 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 e nsuring 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.
Bayer’s corporate culture is an important factor in the company’s success. Central to this culture are our values: Leadership, Integrity, Flexibility and Efficiency, summarized by the term LIFE. They provide us with guidance for our daily work as we seek solutions to the major challenges of our time, in line with our mission statement “Bayer: Science For A Better Life".

Job description
The Senior Validation Specialist will be responsible for the following:
•Lead creation and execution of validation deliverables (protocols, tests, IQ/OQ/PQ, etc). Responsible for reviewing, executing and approving validation documents. Ensure validation documentation is in compliance with Site and Corporate policies and procedures. Ensure validation follows a lifecycle Approach from URS development through system retirement. Provide validation input for periodic Quality reviews. Work closely with business stakeholders, technical support groups and QA to thoroughly investigate validation discrepancies and drive best-practice for systems validation;
•Analyze, plan, design develop, implement and document non-complex or portions of complex information technology projects, which are aligned with company goals. Contributes ideas and suggestions to the project team. Assists in the development of the project plan and the scheduling of project activities. Provides status updates regarding project activities as required by the Project Leader or management;
•Interact directly (when called) with regulatory inspectors to present and defend validation activities and efforts;
•Lead validation team including junior team members and consultants/contactors;
•Supports continual alignment of the business process with other business functions and the IT strategic direction;
•Collaborate with iPASS BPAs to review requirements and ensure they are aligned to validation, compliance, business and 21 CFR Part 11 needs;
•Works on problems of diverse scope in which analysis of situations or data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Normally receives no instruction on routine work, general instructions on new assignments;

Requirements:
Your qualifications The selected candidate is required to possess the following:
•B.S. Biological Sciences, Computer Sciences or related discipline.
•Seven years of experience in a cGMP environment or validation of IT applications, or an equivalent combination of education and experience.
•Experience in using IT systems in a GMP environment.
•Knowledge of GMP and EU regulations including 21 CFR Part 11
•System Development Life Cycle (SDLC) methodologies
•Experience in the implementation and validation of stand-alone IT applications as well as complex enterprise systems such as ERP, EDMS, and LIMS.
•Requires demonstrated technical proficiency, creativity, collaboration with others and independent thought.
•Good technical documentation writing skills.
•Proficient computer skills.
•Strong attention to detail.
•Good communication and interpersonal skills.
•Must be a team player and be conscientious and dependable.
•Must be able to work independently and adhere to timelines.

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.
Salary and grade level will be commensurate with experience and/or education level