Validation Specialist (4843487_Andover)
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.What You Will Achieve
The Instrument Validation Specialist will support a diverse variety of Quality Control and Manufacturing instrumentation, including analytical and microbiological instruments, maintaining the validated state of the instruments from implementation through their full lifecycle. This role will also provide technical support for continuous improvement projects, including data integrity initiatives, driving the projects to completion to support the ongoing activities within the laboratory and manufacturing environments.How You Will Achieve ItROLE RESPONSIBILITIES
This position will provide support for the Validation Program and Validation projects at the Pfizer Andover site.
Work with Operations, Quality, Technical groups, and other site/network groups as required assisting with establishing business and compliance requirements of instrumentation and processes.
Plan and coordinate the validation/qualification work assigned, including Validation Plans, Validation Strategy, Requirements Specifications, Qualification protocols, and Impact / Risk Assessments.
Providing technical support and participating in the implementation of change controls and commitment action items.
Providing technical support and supporting ongoing investigations.
Maintaining inspection readiness.
Technical understanding of process and instrumentation to be qualified.
Skilled at the use of Enterprise systems including, but not limited to site Quality Tracking System (QTS), Laboratory Information Management System (LIMS), Empower and/or Chromatographic applications and Pfizer document repositories.
Applying technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPs.
Role will be expected to work Monday – Friday standard shift. Weekends or off hours may be required as needed.
The incumbent in this position will be responsible for supporting and implementing the established validation approach. Assisting with supporting the site’s successful adherence to the Validation Master Plan, Validation SOP’s, and that validation executions meet all applicable Pfizer quality and compliance standards and applicable regulatory standards.
The position requires BS engineering or science degree with 4+ years of experience or a MS engineering or science degree with 2+ years of experience or equivalent.
Experience is in the area of validation activities supporting manufacturing and development operating in regulated environment.
Candidate is required to be experienced with Pharmaceutical Validation requirements and/or Medical Device Validation requirements (CFR 811).
Experience also required: background in problem solving, negotiations, data integrity principles, and project management/support in a matrixed reporting environment.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Some occasional weekend or second shift work if required.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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.
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.Quality Assurance and Control#LI-PFE