Bayer Senior Manager Process Validation in Berkeley, California
Your tasks and responsibilities
Position Purpose: The Validation Manager coordinates, supervises, directs, and performs all validation activities for facilities, utilities, processes equipment and computer systems associated with new, modified, or existing facilities. Responsible for ensuring that the validation requirements associated with each of these elements in the technology area(s) are researched, defined, and completed in accordance with approved plans and schedules, in support of Division business objectives, Bayer Directives and regulatory requirements and expectations: interpreting evolving regulatory requirements and expectations, and for recommending validation strategies; developing alignment on site Validation strategies and documenting the agreed to validation strategies in documents including Validation Plans and SOPs.
Major Tasks: 1. Provide 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 a wide range of processes, systems 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. Plan, coordinate, and manage site validation activities of new, modified, and existing Bayer facilities. Manage resources to ensure timelines, budget and milestones are met. Ensure all personnel (Bayer or contractors) utilized to perform validation activities have the appropriate skill set and required trainings. 4. Coordinate, manage and where required perform the following: a. risk assessments for validation testing with participation of QA, Production, MS, GBD and Engineering 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; 5. Support validation review of investigations and change management. 6. Provide departmental and site management with periodic site Validation status updates. 7. Support facility inspections, audits (both performed by internal groups and by regulatory agencies), regulatory submissions and requests and annual product reviews.
Who you are
Your success will be driven by your demonstration of our LIFE (Leadership, Integrity, Flexibility, and Efficiency) values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
Qualifications (Education, skills, experiences and personal characteristics necessary for success in this position):
B.S. in Engineering, Biology, Chemistry, Biochemistry or related field 8 years of Pharmaceutical and/or Biotechnology experience including facility, utility, process, and equipment validation experience, and 5 years supervisory/managerial experience, or an equivalent combination of education and experience. • Excellent working knowledge of cGMP and validation requirements • Experience in the development and execution of validation protocols, and preparation of associated reports • Budget management • Excellent inter-personal skills • Project management skills • Ability to direct and develop personnel under his/her direct supervision • Thorough knowledge of and application of current Good Manufacturing Practices and validation requirements, as well as the development and execution of validation protocols, and preparation of associated reports. • Familiarity with large-scale biotech manufacturing processes and/or aseptic filling and lyophilization. • Appropriately allocates effort among several goals • Exhibits sound judgment by: evaluating problems thoroughly, soliciting input and ideas, and using a systematic decision making approach. • Appropriately challenges the status quo and uses knowledge and experience to continuously improve work processes • Takes ownership over ones own development • Gives behavioral feedback and provides long-term coaching
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer Minorities / Females / Protected Veterans / Disabled