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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 Sr. Validation Engineer is responsible for the theory and content of validation documents for terminal sterilization processes and component washing as well as the on-going review, verification and revalidation of said items to ensure that validation documentation is compliant with Plant and Corporate validation requirements and policies. In addition, they are responsible for planning, tracking and reporting on major review/revalidation activities. Assumes the supervisory responsibilities of reporting technicians and engineers. Serves in the role of Validation Manager or Section Manager in their absence.
1. Work closely with Validation Change Owners to plan and draft validation documents compliant with Plant and Corporate policies and procedures; ensure proper execution/documentation of test results, and compilation of validation packages. Responsible for reviewing, executing and approving validation documents.
2. Present or work closely with the Validation Change Owners to present proposed validations to the Plant Validation Review Board and completed validations to regulatory and third party representatives during inspections and audits.
3. Ensure validation packages contain all relevant information, rationales, references, and data to support the change and that all reports and protocols are reviewed and approved as appropriate
4. Perform data analysis of site processes.
5. Assist the Validation Change Owners with the process of obtaining validation package approvals.
6. Develop and maintain an annual plan of cleaning validations and continued process verifications / process validations to be completed during each calendar year, and periodically report on progress.
7. Supervise validation engineers and technician(s) and validation consultants to provide project and technical direction, as needed.
8. Provides technical training in validation to plant personnel.
9. Write or assist with the writing of Standard Operating Procedures and Validation Master Plans
10. Review and provide feedback to plant and corporate policy writers on new and revised validation guidelines, specifications and policies
11. Perform other related duties as assigned or required.
• Bachelor's Degree in Engineering: Mechanical, Chemical, Electrical, or Biomedical or related science.
• Must have a minimum of five (5) years' experience in a pharmaceutical GMP environment. Must have a minimum of two (2) years direct validation experience. Candidates with other technical Bachelor's degrees will be considered if they have four (4) or more years of direct validation experience.
• A minimum of two (2) years of supervisory experience is required.
• Must have thorough knowledge and understanding of cGMPs, FDA and pharmaceutical industry guidelines. Expertise in one of the following disciplines is required: manufacturing, facilities/utilities, laboratory, solution processes, sterilization, and/or controls systems/software. Must have experience talking/interacting with regulatory and third party representatives.
• Must have good organizational, presentation, meeting facilitation and technical writing skills. Working knowledge of statistics is preferred.
• Requires a high level of resourcefulness, an ability to get things done by removing obstacles, identifying and resolving problems, making difficult decisions with less than complete information provided, and finding ways to accomplish goals through innovative planning.
• Must maintain a thorough working knowledge of the Hospira Specification Systems. A high level of attention to details and the ability to proofread and audit validation documents is required.
• Must be able to work weekends and holidays as required to meet deadlines.
Must be able to manage complex projects, set/achieve timelines, direct/redirect resources and manage assigned funding.
Must be able to lift up to 25 lbs. unassisted.
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 16
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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