07 Oct, 2021

Aseptic Process Engineer

  • Pfizer
  • Rocky Mount, NC, USA
Process Engineer Biochemicals / Pharmaceuticals

Job Description

Why Patients Need You

Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action.


What You Will Achieve

Working with Pfizer’s dynamic Aseptic Engineering Team, you will be responsible for the planning, execution, tracking, and completion of key aseptic related projects such as (but not limited to): PQS review/implementation, shut down/restart process, Aseptic Review Board, media fill planning and oversight, investigations, smoke studies, aseptic technique evaluation, sanitation and change management. Your production engineering skills will help in recommending and implementing improvements, modifications or additions that will help in solving problems.


As an associate, your focus on the job will contribute in achieving project tasks and goals. It is your domain knowledge, commitment, collaboration and dedication that will help us achieve new milestones and patients across the globe.


How You Will Achieve It

  • Maintain working knowledge of Current Good Manufacturing Practices (cGMPs) and emerging regulatory and compliance concerns as related to aseptic manufacturing.
  • Liaise with cross-functional teams such as Manufacturing, Maintenance, Quality, Engineering, and Aseptic Trainers for projects and tasks that impact the aseptic manufacturing areas.
  • Contribute to the completion of project milestones, organize own work to meet project task deadlines and communicate progress on scheduled projects.
  • Lead or support major equipment related investigations and implement equipment corrective or preventative action and performance improvements.
  • Participate in aseptic process simulations (media fills) and airflow visualization studies (smoke studies)
  • Ensure integrity and compliance of data according to Standard Operating Procedures.
  • Coordinate all work on scheduled projects (personnel activities, documentation and outside resources).
  • Perform necessary assessments of aseptic operation and update necessary documents.
  • Assist in document preparation and training.





  • Bachelor's Degree
  • Demonstrated ability to provide technical solutions for complex problems through equipment and process understanding
  • Working knowledge of Food and Drug Administration Regulations, and Good Manufacturing Practices
  • Proactive, has experience with high performance teams, strong interpersonal and project management skills
  • Strong written and verbal communication skills
  • Microsoft Applications skills



  • Demonstrated experience in a relevant manufacturing environment
  • Knowledge and experience with Drug Product processing and equipment


Other Job Details:

Last Date to Apply for Job: October 21st 2021
    Eligible for Relocation Package: NO
    Eligible for Employee Referral Bonus: YES



Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.



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.

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