100,000's of Government Jobs

Search Government Jobs

Job Field: Office Jobs
Location: Berkeley, CA
Salary: $Not stated

JOB SUMMARY:

---

</tr>
<tr><td valign="top" width="450"><b>Bayer HealthCare is a leading global specialty pharmaceutical and biotechnology company, and the San Francisco Bay Area is home to more than 1,800 employees focused on the research, development and manufacture of biologics. At Bayer''s Berkeley campus, employees ensure clinical manufacturing and process development of new protein worldwide. A second supply center is located in Emeryville where Bayer manufactures one of the first biologic therapies introduced for the treatment of multiple sclerosis and safely used by patients in more than 100 countries for nearly two decades. Our Sunnyvale location is part of the Bayer Diabetes care group. Discovering novel new medicines is the mission of Bayer scientists. Mission Bay is home to Bayer''s new U.S. Innovation Center where scientists working in the fields of biologics and hematology research reach out and collaborate with academic institutions and small life science companies with the goal of improving patient care and patient outcomes. Systems and Utilities 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.This position is responsible for ensuring maintenance of the validated state of facilities, utilities and equipment.Major Tasks:1. Provides effective leadership including: individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area; supporting workforce diversity, quality and safety and supporting supervisors in the management of their employees/department which support achievement of individual/department/business objectives.2. Determine and establish validation requirements for facilities, utilities and equipment, consistent with Corporate Directives and regulatory expectations. Develop and maintain/ update all necessary Validation Plans and including strategies, work, schedule, and resource planning/ requirements. Develop and maintain/ update Validation SOPs to ensure consistent application of the requirements and strategies.3. Coordinate, manage and where required perform the following:a. Risk assessments to support validation strategy.b. Protocol development/ review/approval, protocol execution, discrepancy and report generation for FAT, SAT, Qualification and Validation as required.c. Training of personnel performing validation activities.d. Support development of other lifecycle documentation including user/ system requirements, risk assessment, design qualification, process development protocols. Review and approve as required by site procedures.e. Resolution of test failures and deviations; ensure sound compliance rationale is developed and documented where exceptions are accepted;4. Ensure Compliance of Facilities, Utilities and Equipment including:

KEY REQUIREMENTS:

---

Not stated