Validation Associate Engineer

ROLE SUMMARY

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

ROLE RESPONSIBILITIES

• Schedules and executes validations/qualifications per Standard Operating Procedures (SOPs), protocols and regulatory guidelines.
• Coordinates and communicates all testing with affected functional groups and evaluates test results.
• Executesvalidation activities to include Change Control initiation, protocol preparation, scheduling, protocol execution, data review and final report generation.
• Participate and present data in Regulatory Agency, Customer, Corporate and Internal audits when necessary.
• Participate in development/ improvements to the validation program as needed to remain current with cGMPs and industry standards.
• Participates on teams assembled to specify, install, validate, troubleshoot and maintain processes, systems and equipment.
• Participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).

BASIC QUALIFICATIONS

• BS/BA degree in science, engineering, manufacturing technology or closely related field is required, and/ or combination of BS/BA degree and relevant work experience is required, with prior pharmaceutical industry experience preferred.
• 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 interact with varying levels within the company.
• Must be able to work multiple shifts as needed to meet deadlines.

PREFERRED QUALIFICATIONS

• Relevant experience or Internship / Co-Op experience in pharmaceutical, engineering, or manufacturing industries highly preferred.
• Excellent attention to detail and working knowledge of FDA Regulations/Guidance and / or Good Manufacturing Practices is preferred.
• Some knowledge and experience with process, equipment, facility, utility or computer system validation, as related to sterile products and medical devices preferred.

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.
• 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 and weekends will be required, as needed. Some travel, < 10% may be periodically required.

#MONSTER

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.