Senior Validation Engineer

ROLE SUMMARY

As a Senior Validation Engineer you will be responsible for validating/qualifying the systems used to manufacture drug products within a large manufacturing facility located in North Carolina, USA. You will help to demonstrate 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) 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.
• 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 presentation of results to Regulatory Agency, when necessary.
• 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.
• Participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
• May supervise and/or mentor junior level engineers.

BASIC QUALIFICATIONS

• Degree Requirements:
  • BS/BA degree in science, engineering, manufacturing technology or closely related field with 3+ years of experience
  • Master's degree in science, engineering, manufacturing technology or closely related field with 1+ years of experience
  • PhD/ JD in science, engineering, manufacturing technology or closely related field with 0-3 years of experience
• Excellent attention to detail and working knowledge of FDA Regulations/Guidance and Good Manufacturing Practices
• Knowledge and experience with validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems is required, as related to sterile products and medical devices is preferred
• 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

• Experience in pharmaceutical industry is preferred
• Experience with executing protocols for autoclaves, sterilizers, and similar equipment is preferred.
• Experience with temperature mapping (Kaye Validator, or similar), equipment risk management systems, and/or aseptic processes 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,

OTHER INFORMATION

• Last Date to Apply for Job: 12/8/2020
• Additional Location Information: Rocky Mount, NC
• Eligible for Relocation Package
• Eligible for Employee Referral Bonus
• #LI-PFE

Sunshine Act

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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