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Validation Section Manager

Pfizer


Location:
McPherson, KS 67460
Date:
11/16/2017
2017-11-162017-12-17
Pfizer
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Job Details

Reporting to the Validation Manager, the Validation Section Manager is responsible for the establishment and execution of the validation strategy for a given sector of validation (i.e., equipment, sterility assurance processes, Process and cleaning validation etc.) to ensure that the validation documentation is compliant with plant and corporate validation requirements and policies. This position will also be responsible for ensuring validation practices are compliant with all of the most current applicable regulatory requirements and are current with industry standard. In addition, they are responsible for prioritizing, tracking, and reporting of major validation initiatives, including resources (both physical and personnel) and capital validation budget. **ROLE SUMMARY**



Reporting to the Validation Manager, the Validation Section Manager is responsible for the establishment and execution of the validation strategy for a given sector of validation (i.e., equipment, sterility assurance processes, Process and cleaning validation etc.) to ensure that the validation documentation is compliant with plant and corporate validation requirements and policies. This position will also be responsible for ensuring validation practices are compliant with all of the most current applicable regulatory requirements and are current with industry standard. In addition, they are responsible for prioritizing, tracking, and reporting of major validation initiatives, including resources (both physical and personnel) and capital validation budget.







**ROLE RESPONSIBILITIES**



1. Accountable for assuring the compliant validation of a given sector of validation (i.e., equipment, sterility assurance processes, Process and cleaning validation etc.) , which requires formal validation documentation per governmental regulations



2. Coordinating activities with customers, internal operating personnel, identifying current and anticipated requirements for compliant processes, suggesting methods for implementation of process improvements, actions and documentation necessary to assure compliance



3. Reporting the status of validation activities to fulfill regulatory requirements, and keeping abreast of changing regulatory requirements, government audit policies and the availability of current techniques.



4. Assists in the presentation of validation documentation to regulatory and third party representatives during inspections and audits. Reviews and approves the validation sections of the NDA's and AND's.



5 Responsible for oversight of a given sector of validation (i.e., equipment, sterility assurance processes, Process and cleaning validation etc.)



6 Supervise 4-5 exempt FTE and contractor support



7 Writes Validation Master Plans and remediation plans as needed. Makes sure all periodic review and/or revalidation activities are completed on time to ensure systems and processes remain in a controlled/validated state.







**QUALIFICATIONS**







+ Bachelors' Degree required 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.



+ Must have a 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.



+ Must have 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.







**PHYSICAL/MENTAL REQUIREMENTS**



Responsible for the review of the integrity of validation reports which includes analyzing and interpreting data and results. Must be able to make and defend decisions on acceptability of qualification and validation activities based on document acceptance criteria, regulatory guidance, and company policy.







**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



Position is 1st shift Mon-FRI with adjustments as necessary to support operations







**EEO & Employment Eligibility**



Pfizer 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. Pfizer 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. Pfizer is an E-Verify employer.







**Sunshine Act**



Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.







+ **Last Date to Apply: November 29, 2017**



+ **This job is a Hospira Exempt US Grade: 18**



+ **RELOCATION ASSISTANCE WILL BE PROVIDED**







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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