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Lead Validation Specialist

Employer
Pfizer
Location
Chesterfield, Missouri
Salary
Competitive
Closing date
Feb 6, 2022

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Discipline
Other, Other
Position Type
Full Time
Organization Type
Pharma
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ROLE SUMMARY

The Lead Validation Specialist is a new position within the Chesterfield Manufacturing Facility (CMF) organization. This position is responsible for oversight of sustainable validation programs in support of GMP manufacturing. The CMF is responsible for manufacture of DNA plasmid starting material derived from microbial culture processes, and Regulatory Toxicology supplies in support of Pfizer's gene therapy portfolio. This position will be a part of the newly created CMF Operations Support team.

ROLE RESPONSIBILITIES
  • Oversight of sustainable validation program and ownership of Validation Master Plans.
  • Lead and perform periodic reviews on GMP equipment, re-qualification of GMP autoclaves, re-mapping of chambers.
  • Author qualification protocols for new equipment and ensure execution of qualification activities.
  • Support qualification activities required by change controls (equipment and automation).
  • Support all change controls, investigations and audits as needed.
  • Interact with operations and engineering to understand equipment/project requirements and coordinate qualification timing and resources.
  • Provide direction to junior colleagues on work tasks.


BASIC QUALIFICATIONS
  • Bachelors in an engineering, scientific or related discipline
  • 10+ years of experience in regulated industry


PREFERRED QUALIFICATIONS
  • Demonstrated experience in a matrix team environment and interacting with Project Management, Manufacturing, Compliance, and Quality. Direct experience with equipment validation highly desired.
  • Strong attention to detail, along with excellent communication and collaboration skills.
  • Strong decision-making skills, routinely demonstrated in highly complex environments.
  • Ability to work independently and complete deliverables with little guidance.
  • Experience in a cGMP environment with increasing responsibility is desired. Management experience is also highly desirable.


PHYSICAL/MENTAL REQUIREMENTS
  • Collaborative skills and effective partnering skills in complex working environments
  • Ability to work in a dynamic multi-discipline organizational model


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
  • Ability to work in a clean room environment


Other Job Details

Relocation support available

#LI-PFE

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.

Research and Development

#LI-PFE
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