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Senior Instrument Validation Specialist

Employer
Pfizer
Location
Andover, Massachusetts
Start date
Sep 27, 2022

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Discipline
Clinical, Clinical Medicine
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown, Best Places to Work
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Job Details

Why Patients Need You

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 AchieveThe 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 ongoing activities within the laboratory and manufacturing environments.

How You Will Achieve It
  • 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.

Qualifications
  • 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 in the area of validation activities supporting manufacturing and development operating in regulated environment.

  • Candidate is required to be experienced with Pharmaceutical Validation requirements.

  • Experience also required: background in problem solving, negotiations, data integrity principles, and project management/support in a matrixed reporting environment.



PHYSICAL/MENTAL REQUIREMENTS

N/A


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Some occasional weekend or second shift work if required.


Work Location Assignment:On Premise

Relocation assistance may be available based on business needs and/or eligibility.

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.

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.

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.

Engineering

#LI-PFE

Company

Join world-class scientists and leaders who are dedicated to bringing therapies that will significantly improve patients' lives.

As one of the world's premier innovative biopharmaceutical companies, we're driven to discover the cure --driven to significantly improve the lives of everyone...everywhere. If you're similarly driven, you'll find there's no better place to begin --and continue --your career than at Pfizer.

Science is the foundation of our company.  This is why it's no surprise that the most driven scientists in the world choose to carry out their life's passion at Pfizer.  We arm them with the resources, technology, and facilities they need to solve some of the world’s most complex health challenges. This combination empowers our scientists with expertise in vaccines, small-molecule medicines, biotherapeutics amongst many others, to collaborate on breakthrough science, including the world's first mRNA-Based Covid19 vaccine.  Our colleagues advance science and technologies into the therapies that matter most.

Join us and you'll partner with colleagues of diverse backgrounds and abilities who contribute to all aspects of what we do. Great things happen when people come together with one shared goal. If you're driven to discover the cure- ensure it has the latest technology to make it a reality or help improve the lives of others- join those who are similarly driven at Pfizer. The future of medicine is happening here.

Visit www.pfizer.com and connect with us.

 

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Find Us
Website
Phone
(212) 733-2323
Location
235 East 42nd Street
New York, NY 10017
United States
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