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Equipment Validation Manager

Employer
Pfizer
Location
Sanford, North Carolina
Salary
Competitive
Closing date
Feb 25, 2024

View more

Discipline
Other, Manufacturing/QA/QC
Position Type
Full Time
Job Type
Manager
Organization Type
Pharma
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 Achieve

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.

This position will provide equipment validation support for assets supporting manufacturing processes unit operations large molecule/biologics manufacturing processes, including drug product filling unit operations (isolators) and controlled temperature storage units.The position leads and/or participates in the planning, execution, and summarization of validation protocols for initial qualification or requalification efforts. This role is a senior individual contributor role but will also provide oversight for contract support. At a minimum, the person should be able to execute work independently, work with various groups across the organization, be a self-starter, and be able to oversee and lead projects to ensure that the equipment is validated and is able to maintain the validated state.

In addition, knowledge of electronic systems including document management, LIMS, MS Word and MS Excel will be required as part of the job. The person should be highly motivated, a self-starter, and be able to work with a team on projects as well as on their own.

It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It
  • Responsibilities include the following:
  • Equipment validation activities. Activities include
    Coordinating qualification/requalification schedule times with system owners

    Generating and executing protocols and writing final reports

    Sampling /execution

    Generating of regulatory submission documents

    Project management of overall and individual EQV projects and activities

    Oversight of contractors who may assist with these activities
  • Write validation impact assessments for investigations or protocol non-conformance reports
  • Complete validation impact assessments for change controls
  • Ability to manage multiple projects and activities of moderate complexity simultaneously.
  • Support regulatory inspections through the preparation, defense and interaction with auditors in areas related to process and cleaning validation.
  • Work to implement a culture of Right-First Time and continuous improvement relative to equipment validation procedures and systems.
  • The position requires execution and management of multiple projects at the same time and good communication skills to keep customers, peers, area management and site leadership up-to-date with progress of all projects in order to ensure validations are completed in a timely manner and on schedule.



Qualifications

Must-Have
  • Applicant must have a High School Diploma (or Equivalent) with 10 years of relevant experience; OR an Associate's degree with eight years of experience; OR a Bachelor's degree with at least five years of experience; OR a Master's degree with more than three years of experience; OR a Ph.D. with 0-2 years of experience.
  • Excellent verbal and written communication skill s (proficiency in the English language).
  • A bility to build relationships with internal and external stakeholders to influence outcomes .
  • High proficiency in Word, Excel.
  • Previous experience in equipment validation.
  • Project Management experience.
  • E xperience working in the pharmaceutical manufacturing industry.


Nice-to-Have
  • Experience with isolator qualification.
  • Previous experience with defending validation packages to auditors/Boards of Health.
  • Experience with computerized system validation.
  • Experience overseeing contract resources.
  • Proficiency with LIMS or similar system.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Schedule is primarily day shift but may require off-shift work on occasions. The position may require working on the floor in manufacturing at times which will require a heightened safety awareness and aseptic gowning will be required.

Relocation support available

Work Location Assignment:On Premise

Last Date to Apply: February 21, 2024

The annual base salary for this position ranges from $93,500.00 to $155,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

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

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. This position requires permanent work authorization in the United States.

Quality Assurance and Control

#LI-PFE

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