| Description
Meet the new Merck. A stronger pipeline. More products to help people in more ways. More passionate than ever about what matters to our customers.
Merck and Schering-Plough are now one company. We recently merged to create a stronger, more diverse and more truly global company. This not only benefits our company and our shareholders, but it also benefits the millions of people around the world who rely on our products and expect us to continue to deliver exceptional value.
The Validation Manager will play a leadership role in the site technical organization supporting sterile formulation and filling of live virus vaccines. The facility includes formulation, vial filling line in isolators, inspection systems, development laboratory, and support equipment (e.g. autoclaves, stopper processors).
Responsible and accountable for developing and executing validation strategy for process, cleaning, and sterilization. In support of process/product start up of the facility, responsible for executing against the VMP, developing the cleaning and sterilization cycles, ensuring the container closure and filter validations are complete, and completing the process, cleaning and sterilization validation. Work involves validation SOP development, protocol preparation, study execution, investigation of results, report writing, preparation of regulatory submissions, interacting with regulatory inspectors, and project planning and management.
Responsible for recruiting, developing, and leading a group of 5 to 10 validation scientists. Demonstrate commitment to a site vision and guiding principles for an empowered team based environment.
As this position is for a new manufacturing site the Validation Manager will have significant input in developing the validation approach and play a key leadership role in planning and executing the start-up.
Core Responsibilities
- Validation Strategy
- Technical Support of Operations
- Cleaning, Sterilization, and Process Validation
- Compliance
- Personnel
Core Competencies
Flexibility; Motivating; Functional Excellence including validation system and life cycle documentation expertise and sterile/aseptic expertise; Teamwork/Collaboration; Results-Oriented; Problem-Solving; Communication. Actively supports, participates and embraces an empowered team culture. Qualifications Qualifications:
- Minimum of a B.S. in Engineering or Science required. M.S. or PhD. in Engineering or Science will be considered. Preferred fields of study include Chemical Engineer, Biochemical Engineer, or Biological Sciences.
- Minimum of 8 years with all or some of experience in a sterile validation or Quality experience required (can be obtained through a combination of post-graduate education and work-related experience). Minimum of 6 years of the above noted experience is required if MS or PhD degree has been attained
- Demonstrated leadership and teamwork skills, excellent analytical abilities, proven written and verbal communications skills.
- Experience preparing regulatory submissions and managing interactions during regulatory inspections required.
- Ability to gain cross-functional consensus and skilled in conflict resolution.
- Knowledge of PDA Technical Reports, active member of PDA or other recognized industry group, is preferred.
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
To be considered for this position, please visit our career site at www.merck.com/careers to create a profile and submit your resume for requisition # CHE002102. Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations.
Search Firm Representatives
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