04 Jan, 2021

Process Engineer - Gene Therapy Manufacturing Technical Services

  • Pfizer
  • Sanford, 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, science and engineering are vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative Technical Services 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 Downstream Technical Service team, you will play a critical role in design and development of manufacturing process to bring products from research to manufacturing. You will leverage your technical capabilities to understand the inherent problems related to transfer of technology from the research stage to manufacturing, in cooperation with pilot-plant and production departments. You will conduct tests and measurements throughout the stages of production and troubleshoot production process problems with processes or equipment already in operation.

As a Process Engineer, your knowledge and skills will contribute towards the goals and objectives of the team.  Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will make it easy to manage difficult issues and help in establishing consensus between teams.

It is your dedication and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

 

How You Will Achieve It

  • Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for activities on own projects.
  • Lead process, product and device improvements, create data packages by justifying recommendations for improvements in production processes and collaborate with technical staff to implement process technology initiatives.
  • Author protocols for process and cleaning validation, execute the validation studies in partnership with Operations Departments and write validation reports.
  • Provide technical leadership in investigations to determine root cause and implement appropriate corrective and preventive actions.
  • Develop process flow diagrams for illustrating critical process and material flow.
  • Assist Technology Transfer, including Gap Analysis and Process Transfer Risk Assessments.
  • Partner with manufacturing to meet the production schedule, ensure commercial supply, uphold quality standards and driving towards zero defects.
  • Analyze, apply, and interpret information and identify cause and effect relationships.
  • Contribute to continuous improvement of current operations to improve Overall Equipment Effectiveness (OEE), quality and/or productivity using current methodologies.

 

Qualifications

 

Must-Have

  • Bachelor's Degree with 3+ years of demonstrated experience in process or quality engineering in a pharmaceutical / medical device setting
  • Demonstrated technical capability and aptitude for technical learning
  • Sound understanding of statistical experimental design and analysis
  • Experience with  purification technology (chromatography, filtration, etc.)
  • Ability to work on own initiative
  • Ability to think outside-the -box and make decisions with limited data or ambiguous situations
  • Excellent communication skills and fluency in English

 

Nice-to-Have

  • Master's degree
  • Relevant pharmaceutical experience
  • Previous experience executing as a Technical Services Scientist {Product transfers, Process and Cleaning validation experience}
  • Validation and analytics knowledge
  • Basic knowledge of Delta V
  • In-depth knowledge of statistical principles

 

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

 

May require some travel per business needs

Relocation support available

 

  • Last Date to Apply for Job: 1/13/2021
  • Eligible for Employee Referral Bonus

 

 

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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