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Hospira currently has an opening for a Validation Section Manager at our McPherson, KS location. The individual in this position will work in the Quality Assurance organization as part of the Validation Group and manage a team of 1-5 direct reports. This person is responsible for the establishment and execution of the validation strategy for a given sector of validation (i.e. equipment, processes, etc.) to ensure that the validation documentation is compliant with plant and corporate validation requirements and policies. 

Job Responsibilities:

• Ensures validation practices are compliant with all of the most current applicable regulatory requirements and are current with industry standard
• Responsible for prioritizing, tracking, and reporting of major validation initiatives, including resources (both physical and personnel) and capital validation budget
• Implements the qualification program, develops qualification procedures for equipment, processes and control systems
• Assumes the supervisory responsibilities of reporting exempts and non-exempts
• Serves as a primary liaison between Validation and Manufacturing, Engineering and the Laboratories on projects/programs requiring design control and validation.
• Guides and influences new product teams through design, validation, and interfaces to regulatory compliance and assures robust product vs. customer/product requirements. 

Job Requirements:

• In place of the three-year supervisory experience, experience in project management/leadership may be considered.
• Bachelors’ Degree in Engineering or Science
• Candidates with other technical Bachelor’s degrees will be considered if they have five (5) or more years of direct validation experience
• Minimum of seven (7) years experience with a pharmaceutical GMP environment in one or more of the following disciplines: Validation, Process/Product Engineering or Quality Assurance
• Must have a minimum of five (5) years of direct validation experience
• Thorough knowledge and understanding of cGMPs, FDA and EU regulations and current pharmaceutical industry standards
• Must have extensive experience talking/dealing with regulatory and third party representatives. Must have good organizational, presentation, meeting facilitation, project/time management and technical writing skills.
• A minimum of three (3) years of supervisory experience is required with supervision of exempts being preferred.

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