Pfizer Instrument Validation Specialist in Andover, Massachusetts
The qualified candidate must have the experience and ability to participate in multiple projects within Quality Control and Andover Site Technical Services. She/He will lead and perform a variety of validation activities to maintain the validation life cycle of QC laboratory instruments (e.g.,validation of new and legacy instruments, performance verification, calibration, software and hardware upgrade through change control, periodic reviews, decommissioning, application administrative support, schedule annual PMs, renewal of instrument service agreements).
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.
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. The required 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 (CFR 211, ICH, Annex 15) 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.
- This job is Pfizer U.S. Exempt Grade 007
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.
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.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.