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 ensure systems are running according to necessary specifications and operate within regulations to ensure data integrity and the production of quality products.
Execute multiple large and small scale projects
Reviews and approves Validation and Change Control documentation
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 lower level Validation team members 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).
BS/BA degree in science, engineering, manufacturing technology or closely related field with 3+ years of relevant experience, and experience in the pharmaceutical industry is strongly preferred OR/
Master's degree in science, engineering, manufacturing technology or closely related field with 1+ years of relevant experience OR/
PhD/ JD in science, engineering, manufacturing technology or closely related field with relevant experience is 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 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
- Experience in the pharmaceutical industry is strongly preferred
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,
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.
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.
Last Date to Apply for Job: 4/27/2019
Additional Location Information: Rocky Mount, NC
Eligible for Relocation Package
Eligible for Employee Referral Bonus
1 (First Shift) (United States of America)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.