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A career at the company offers opportunity, ownership and impact.
All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
The Validation Manager interfaces with site and Corporate representatives to ensure plant validation practices and operating procedures reflect corporate policies and procedures, as well as industry standards and expectations. Responsible for ensuring the site manages product and equipment lifecycles, process, cleaning and other areas in a compliant manner. Manages the Validation Department staff and Consulting resources to fully attain validation objectives.
1. Ensures the facility is operating in accordance to cGMP regulations relative to validation and validation documentation requirements.
2. Ensures validations are performed appropriately through writing, approving, tracking, and performing tests for all phases of validation, i.e. design, validation, continued process verification.
3. Develops and ensures proper execution of validation plans for plant equipment, facilities, utilities, processes, control systems, software, cleaning, etc. This includes validation and periodical reviews and revalidation.
4. Serve as primary interface for validation matters with regulatory and third party representatives and when needed for R & D, technical resources, and vendors.
5. Provide oversight, direction and counsel to other site functions on validation matters: investigations, CAPA management and process improvements related to validated systems.
6. Prioritize and manage the overall validation resources (staff, equipment, and funds) to meet diverse and aggressive goals for validation compliance.
7. Develop depth of resources to assure continuity of validation expertise necessary to meet compliance requirements.
8. Facilitate the Plant Validation Steering Committee to gain consensus on priorities and schedules, which consolidates the compliance and business needs.
9. Assists with the development of metrics, dashboards, score cards, and tracking and trending for validated equipment, facilities, utilities, systems, etc.
10. Obtain consultant statements of work, issue purchase order, process invoices.
11. Provide technical validation training to plant personnel.
12. Participate and facilitate, as needed, the Plant Validation Review Board.
• Bachelor's Degree is required: Engineering or Science. Candidates with other technical Bachelor's degrees will be considered if they have seven (7) or more years of direct validation experience. Management or Business Administration Courses are desirable.
• Minimum of ten (10) years' experience in a pharmaceutical GMP environment in one or more of the following disciplines: Validation, Process/Product Engineering cGMP Compliance or Quality. Experience must include at least five years in direct validation role and five (5) years of managerial experience including supervision of exempts.
• Extensive experience talking/dealing with regulatory and third party representatives.
• Good organizational, presentation, meeting facilitation and technical writing skills.
• Working knowledge of statistics is preferred.
• Strong communication and interpersonal skills.
• Demonstrated leadership skills include providing direction, influencing others, fostering teamwork, motivating others, delegating, coaching/developing others in a team-oriented environment and championing change.
• Demonstrated flexibility and the ability to handle multiple projects.
• Ability to drive for results and show work commitment.
• Ability to analyze large amount of technical and process data, understand verbiage and intent of Governmental and Company regulations, evaluate potential solutions, and determine the most compliant and cost effective approach to solve problems.
• Act with integrity, and show resilience in the face of challenges.
• Must have demonstrated skills to think strategically, analyze issues, use sound judgment and be innovative.
• Must work extended days, weekends and holidays as required to meet deadlines.
Other Information - Internal
Colleagues who are issued any type of progressive disciplinary action on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date disciplinary action is issued.
Legacy Hospira Grade 19
EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
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