Validation Engineer II

Andover, Massachusetts
June 16 2021
Position Type
Full Time
Organization Type
Role Summary

Provide validation support related to qualification of manufacturing processes and equipment used for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio. The validation engineer will assist in qualification activities including, but not limited to IQ/OQ/PQ/RQ, cleaning validation, equipment changeover, chamber qualification, sterilization qualification, steam quality testing, temperature mapping, and periodic review.

Role Responsibilities

Work with Operations, Quality, Technical groups, and other site/network groups as required establishing business and compliance requirements of the asset.
  • Plan and coordinate the validation work assigned
  • Technical understanding of process and equipment to be qualified
  • Accountable for quality of work performed
  • Perform the work in accordance to all the compliance requirements and in a safe manner.
  • Requalification (temperature mapping) of CTUs: Incubators, Refrigerators, Freezers, and Environmental Rooms
  • Sampling of various process equipment in support of the cleaning program (product changeover, cleaning monitoring, performance qualification)
  • Support Sterilization Validations: Autoclaves, Process Equipment, and Transfer Lines
  • Perform periodic reviews of qualified equipment ensuring that the equipment is maintained in a validated state

Basic Qualifications

  • Bachelor's degree in an engineering or scientific discipline +2 years of relevant experience; Associate degree or completion of 2 years of undergraduate work +3 years of relevant experience; or HS diploma + 5 years of relevant experience .
  • Hands-on experience with manufacturing equipment is critical in this roleand selected candidates must be able to operate independently once trained
  • Self-driven and self-accountable to delivery timelines and action items
  • Strong verbal and written communication skills
  • Experienced with cGMP documentation requirements
  • Able to work with cross-functional areas such as quality, micro, operations, and engineering
  • Ability to flex and quickly adapt to changing environment and competing priorities

Preferred Qualifications

  • Experience working in a large scale manufacturing facility
  • Previous experience with cleaning validation and/or temperature mapping
  • Ability to troubleshoot technical issues, plan and carry out studies independently, and work with complex instrumentation and software
  • Excellent oral and written communication skills

  • Must be able to climb flights of stairs and be standing for ~1-2 hours at a time.
  • Must be able to lift up to 25lb
  • Must be able to complete gowning activities.
  • Practical knowledge of the use of Personal Protective Equipment (PPE) to handle hazardous materials throughout site.

  • This is a Monday - Friday 1st shift position (7:30am - 4:00pm).
  • Ability to work off shift (Nights and Weekends) as needed; non-routine
  • Ability to work in a clean room environment
  • Some travel within the Pfizer network may be required

Other Job Details:
  • Last Date to Apply for Job: June 22, 2021
  • Eligible for Employee Referral Bonus
  • #LI-PFE

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 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.

Research and Development

Similar jobs

Similar jobs