Validation Engineer

ROLE SUMMARY

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.

ROLE RESPONSIBILITIES

• 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)

BASIC QUALIFICATIONS

• BS/BA degree in science, engineering, manufacturing technology or closely related field is required.
• Minimum of 1 year of relevant experience in validation is required.
• Excellent attention to detail and working knowledge of FDA Regulations/Guidance or Good Manufacturing Practices is required.
• Technical knowledge and experience with validation / qualification processes, equipment, utilities, facilities and/or computer systems is required.
• 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.

PREFERRED QUALIFICATIONS

• 2 years of experience in the pharmaceutical industry is strongly preferred.
• Validation experience as related to sterile products and medical devices is preferred.
• Experience working with periodic performance qualifications (PPQ), Kaye Validator, Washer, wet loads, equipment loads, and / or sterilizers is 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.

• Eligible for Relocation Package: Yes
• Eligible for Employee Referral Bonus: Yes

#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.