Pfizer Senior Validation Engineer in Rocky Mount, North Carolina
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.
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 validation studies to include protocol preparation, scheduling, protocol execution, analysis of data and final report generation.
Participates in presentation of results to Regulatory Agencies when necessary.
Participates in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards.
Participate and/or lead discussions with internal, customer and regulatory agencies
Prepare responses to internal, customer and regulatory agency audits
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.
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
Experience in pharmaceutical industry strongly preferred
Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices
Knowledge and experience with equipment validation of pharmaceutical processes, as related to sterile products and medical devices 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
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 Job Details:
Last Date to Apply for Job: 9/30/20
Eligible for Relocation Package
Eligible for Employee Referral Bonus
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EEO & Employment Eligibility
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