Org Marketing Statement
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer 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. Pfizer, 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.
Role Description
This position will provide support for the Validation Program and Validation projects at Pfizer Andover site.
The Validation Scientist / Validation Engineer is expected to utilize their own subject matter expertise (SME), as well as collaborate with other site validation SMEs, to define, standardize and support the validation programs and procedures in compliance with corporate, regulatory, and industry standards and regulations.
The incumbent in this position will be responsible for supporting and implementing the established validation approach and is accountable for supporting the site's successful adherence to the Validation Master Plan, Validation SOP's, and the integration of the Master Plan with the Strategic Planning Process.
The incumbent will be expected to partner with the SME's of the site Quality Assurance Validation group to ensure all validation strategies and validation executions meet all applicable Pfizer quality and compliance standards, local SOP's, as well as applicable regulatory standards. The incumbent will be responsible for providing Validation supporting during regulatory inspections. The incumbent will support the development, implementation and maintenance of system(s) for tracking and measuring validation status, resource utilization and effectiveness.
The Validation Scientist / Validation Engineer will also be responsible for supporting the development the next generation validation program.
Responsibilities
* This position will provide support to the Cleaning/Disinfectant validation, Sterilization validation, Equipment validation, Instrumentation validation and Shipping validation.
* Foster a Quality and Compliance culture for the validation program
* Support the validation program and procedural changes that enhance safety, compliance, and overall operational efficiency.
* Continuously evaluate and identify opportunities for improvement in existing validation programs and procedures.
* Support on site governance team that oversee or impact validation program and procedures.
* Accountable for the quality and robustness of validation program and procedure design.
* Represent validation program during audits and inspections
Qualifications
The position requires BS engineering or science with 5+ years of experience in the area of validation activities supporting manufacturing and development operating in regulated environment. Candidate is required to be experienced with Pharmaceutical Validation requirements (CFR 211, ICH, Annex 15) and or Medical Device Validation requirements (CFR 811)
Experience also required, background in problem solving, negotiations, project management/support in a matrixed reporting environment. Six Sigma certification or background is preferred.
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.
Please apply at: Application URL:http://www.aplitrak.com/?adid=SmltLlRhdm9saWVyaS40NjExOS4zMTY3QHBmaXplci5hcGxpdHJhay5jb20