12 Apr, 2021

Senior Process Engineer

  • Pfizer
  • Vizag, Andhra Pradesh, India
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 engineering 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 Senior Associate, 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.
  • Execute laboratory runs and writes technical reports summarizing laboratory results, generating necessary lab data to support product impact assessments during discrepancies and investigations.
  • Partner with manufacturing to meet the production schedule, ensure commercial supply, uphold quality standards and driving towards zero defects.
  • Evaluate new materials and primary packaging components.
  • 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

  • Bachelors or Master’s in engineering (Preferably Automation/Instrumentation/Mechanical / Chemical
  • 6 to 10  years of demonstrated experience in process or quality engineering in a pharmaceutical / medical device setting
  • Holistic understanding on Terminally Sterilized equipment train i.e Formulation process equipments, automation, Filling, and Terminal sterilization
  • Good knowledge / Hands on experience on pharma equipment and its engineering aspects
  • Problem solving skills and Process analytical skills
  • Demonstrated technical capability and aptitude for technical learning
  • Sound understanding of statistical experimental design and analysis
  • Ability to work on own initiative
  • Excellent communication skills, presentation 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 DCS
  • Yellow belt   / Green belt certification

  

 

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


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