Validation Engineer

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 Validation team. You will be responsible for the creation, review and approval of validation master plan, SOPs, protocols and reports. 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 validation problems for equipment and performance processes and conduct statistical analysis of testing results and process anomalies. Your documentation skills will guide the writing, review and approval of validation process documents and technical reports related to equipment, facilities, utilities, computer systems, products and processes.

As a Validation Engineer you will be responsible for validating/qualifying the systems used to develop and/or manufacture products within a large manufacturing facility located in North Carolina, USA. You will ensure systems are running according to necessary specifications and operate within regulations to ensure data integrity and the production of quality products.

How You Will Achieve It

• Execute multiple large and small scale projects
  
• Coordinate/oversee the development of new processes or troubleshoot existing ones.
  
• Schedules and executes validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines.
  
• Coordinates and communicates all testing with affected functional groups and evaluates test results.
  
• Executes equipment, facility, utility, computer system, and Automated Process Control validation studies to include protocol preparation, scheduling, protocol execution, analyze data and compose a final report.
  
• Oversee and assist Associate Engineers and/or Technicians with their assigned projects.
  
• Participates and presents data in Regulatory Agency, Customer, Corporate and Internal audits.
  
• Provide technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGXP, CFR 21 Parts, 11, 210 and 211, EU Annex 11, ICH Q7, Q8 and Q9, and other applicable regulations, procedures and industry guidance.
  
• Thorough understanding of risk based validation for computerized systems, industry standards and best practices for computer system validation, such as, but not limited to GAMP 5 and ASTM E2500.
  
• Perform Electronic Record/Electronic Signature (ERES) Assessments.
  
• Participates in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards.
  
• Participates in teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.
  
• Conducts Validation deviations and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CAPA).
  

Qualifications

Must-Have

• BS/BA degree in science, engineering, manufacturing technology or closely related field with 1+ years of experience required
  
• Years of experience in pharmaceutical industry strongly preferred
  
• Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices
  
• Strong technical knowledge and experience with validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems as related to sterile products and medical devices
  
• Must be proactive, have experience with high performance teams, strong interpersonal and project management skills
  
• Must be able to interact with varying levels within the company
  
• Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results
  
• Strong conflict resolution skills
  
• Must be able to work multiple shifts as needed to meet deadlines
  

Nice-to-Have

• Technical writing experience
  
• Experience with pharmaceutical industry validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems as related to sterile products and medical devices
  
• Working knowledge of Food and Drug Administration Regulations/Guidance, and Good Manufacturing Practices
  
• Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results
  

PHYSICAL/MENTAL REQUIREMENTS

• Must be able to lift and carry light loads as necessary in conducting testing. Weekend or long hours based on testing schedule.
  
• able to manage multiple tasks at once.
  
• May involve standing for long periods of time.
  
• Must be able to wear proper gowning and PPE in manufacturing areas as required to meet GMP and/or OSHA requirements.
  

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Primary work schedule is Day shift, Monday - Friday but evenings, weekends and holiday work may be required, as needed. Some travel, < 10% may be periodically required.

OTHER JOB DETAILS

Last Date to Apply for Job: February 16th, 2024

Eligible for Relocation Package: NO

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.

Quality Assurance and Control

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