Associate Validation Engineer
Company: Pfizer Inc.
Location: Rocky Mount
Posted on: November 9, 2019
As an Associate 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
- 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.
- Participates and presents data in Regulatory Agency, Customer,
Corporate and Internal audits when necessary.
- 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)
- Participates in developments/ improvements to validation
programs as needed to remain current with cGMPs and industry
- 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 is required
- Ability to work both independently and in partnership with
others; proven ability to use initiative and drive to achieve
- Strong conflict resolution skills
- Must be able to interact with varying levels within the
- Must be able to work multiple shifts as needed to meet
- Relevant experience or Internship / Co-Op experience in
pharmaceutical, engineering, or manufacturing industries highly
- Excellent attention to detail and working knowledge of FDA
Regulations/Guidance, and Good Manufacturing Practices is
- Some technical knowledge and experience with
validation/qualification of pharmaceutical processes, equipment,
utilities, facilities and/or computer systems as related to sterile
products and medical devices is preferred
- Must be able to lift and carry light loads as necessary in
conducting testing. Weekend or long hours based on testing
- 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,
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.
Other Job Details:
- Last Date to Apply for Job: 11/12/2019
- Additional Location Information: Rocky Mount, NC
- Eligible for Relocation Package
- Eligible for Employee Referral Bonus
Pfizer is an equal opportunity employer and complies with all
applicable equal employment opportunity legislation in each
jurisdiction in which it operates.
Keywords: Pfizer Inc., Rocky Mount , Associate Validation Engineer, Engineering , Rocky Mount, North Carolina
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