Validation Engineer
Share
Job Location:
Rocky Mount, NC - USA
Monthly Salary:
Not Disclosed
Posted on:
21 hours ago
Vacancies:
1 Vacancy
Job Summary
Use Your Power for Purpose
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. The area of responsibility includes Laboratory Equipment Qualifications (IQ OQ PQ) and requalifications for Controlled Temperature Units (CTUs) - refrigerators freezers incubators for material storage and autoclaves isolators ovens and washers in the Quality Operations Technical Services business unit.
What You Will Achieve
In this role you will:
Perform activities related to qualification GXP validation and change management of Laboratory Equipment / Systems.
Participate in development/ improvement of validation programs as needed to remain current with cGMPs and industry standards.
Plan generate and execute protocols for Periodic Performance Qualifications and Periodic Reviews in accordance with frequency defined in site schedule.
Evaluate test results and analyze data ensuring coordination and communication with affected functional groups.
Participate in cross-functional teams to specify install qualify troubleshoot and provide resolution of issues to ensure equipment are maintained in a validated state.
Support Regulatory Agency Customer Corporate and internal audits through preparation and presentation of laboratory equipment validation packages.
Complete validation deviation records and/or participate in deviation investigations to identify root causes and define corrective and/or preventative actions (CAPA).
Comprehensive understanding of risk-based validation and Current Good Manufacturing Practices (cGMP guidelines outlined in Code of Federal Regulations.
Here Is What You Need (Minimum Requirements)
Applicant must have a bachelors degree science engineering or manufacturing technology or closely related field preferred with 0 years of experience; ORan associates degree with 4 years of experience; OR a high schooldiploma (or equivalent) and 6 years of relevant experience
Working knowledge of Food and Drug Administration Regulations and Good Manufacturing Practices
Proactive with experience in high-performance teams strong interpersonal and project management skills
Proficiency in Microsoft Applications
Bonus Points If You Have (Preferred Requirements)
Technical writing experience.
Strong communication with written and verbal skills.
Strong conflict resolution skills.
Experience with pharmaceutical industry validation/qualification processes and laboratory equipment.
Ability to work independently and in a team environment in partnership with others.
Proven ability to use initiate and drive to achieve results.
Proficiency with Kaye Validator and Ellab instrumentation for thermal mapping calibration and qualification studies.
Work Location Assignment:On Premise
Relocation assistance may be available based on business needs and/or eligibility.
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 providers 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. This position requires permanent work authorization in the United States.
Pfizer endeavors to make to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing please email. This is to be used solely for accommodation requests with respect to the accessibility of our website online application process and/or interviewing. Requests for any other reason will not be returned.
Required Experience:
IC
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
Erfahren Sie mehr über uns als forschendes und produzierendes Pharmaunternehmen: Von unserem Beitrag zum medizinischen Fortschritt bis zur nachhaltigen Produktion.
