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Validation Engineer II

Employer
Pfizer
Location
McPherson, Kansas
Salary
Competitive
Closing date
Apr 16, 2024

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Sector
Pharmaceutical
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional
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

You will be a member of Pfizer's dedicated and highly effective team focused on technical transfers, new initiative & improvement projects, Performance Qualifications, Requalification and media fills as applicable. You will be responsible for assigned qualification execution, ownership of protocols and reports, ownership/execution of projects. Your methodological approach will help us ensure compliance of our quality systems with company standards and government regulatory requirements. Your problem-solving ability will help us troubleshoot tech services related problems for performance processes and conduct statistical analysis of testing results and process anomalies. Your documentation skills will guide the writing, review and approval of for validation process documents and technical reports related to equipment, products and processes.

As an associate, your focus on the job will contribute to achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues. 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

  • Report to the Validation Management, the Validation Engineer will assure that equipment, facilities, and utilities are validated in accordance with current Good Manufacturing Practices (cGMP) principles, regulatory requirements, and company policies and standards. Lead & contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
  • Perform/maintain manufacturing equipment & processes qualifications for example: IQ, OQ, PQ, Requalification, Media Fills or projects as assigned for the Pfizer/McPherson site. Organize with other departments to meet validation deliverables for activities and Projects.
  • Own and complete development of validation protocols & reports. Participate in deviation investigations to identify root causes and define corrective and/or preventative actions.
  • Adhere to all company and cGMP procedures, along with safety regulations within the plant and participates in developments of validation programs as needed to remain current with cGMPs and industry.
  • Work effectively as a member of the Tech services support cGMP as well as directly with Business Area Training Leads / Coordinators and SMEs within to support cGMP.
  • Determine process capability of new equipment through execution of approved protocols and assure defined parameters are incorporated into respective operating procedures and batch records.
  • Support and present documentation as needed for regulatory inspection. Assists with development of validation protocols and manage Regulatory queries and responses.
  • Adhere to all company and cGMP procedures, along with safety regulations within the plant and participates in developments of validation programs as needed to remain current with cGMPs and industry.
  • Define problems, collect data, establish facts, and draw valid conclusion. Summarize the study reports for approval and completion.


Qualifications

Must-Have
  • Bachelor's degree with 1+ years of relevant experience in cGMP quality or validation/technical services or manufacturing OR
  • Associate degree with 4 years of relevant experience in cGMP quality or validation/technical services or manufacturing OR
  • High School Diploma (or equivalent) with 6 years of relevant experience in cGMP quality or validation/technical services or manufacturing
  • Excellent attention to detail and working knowledge of Food and Drug Administration Regulations/Guidance, and Good Manufacturing Practices.
  • Excellent organizational skills, and ability to handle changing deadlines.
  • Strong communication with written and verbal skills.
  • Working knowledge of Microsoft Office, especially Excel for evaluation of data.


Physical/Mental Requirements
  • Requires routine sitting, standing, walking, listening and talking
  • Acute mental and visual attention at all times
  • Handle multiple projects while managing frequent interruptions
  • Requires moderate lifting or moving up to 25 pounds


Non-Standard Work Schedule, Travel, or Environment Requirements
  • Must have the ability to work effectively under strict deadlines
  • The McPherson Site is a 24/7 operation. Must be able and willing to work outside of typical business hours to support the business, which may include weekends and holidays


Other Job Details
  • Last day to apply: March 14, 2024
  • Relocation support available
  • Work Location Assignment:On Premise


The annual base salary for this position ranges from $64,600.00 to $107,600.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% of the base salary. 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

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