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 developing and modifying process formulations, methods and controls to meet quality standards. Your production engineering skills will help in recommending and implementing improvements, modifications or additions that will help in solving problems. You will review product requirements in terms of product development compatibility and help Pfizer determine optimum costs and schedules of production.

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 facilitate in explaining difficult issues and establishing consensus between teams.

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

Role Summary

Develops and executes process recipe parameter enhancements and creation, methods and controls to meet quality standards. Recommends and implements improvements, modifications or additions which will document work; tests and solves problems. Review product requirements and work with support functions to develop recipes, test plans, and qualification activities. Activate Troubleshooting or Reliability teams as needed integrating cross-functional teams. Seek for necessary support internally, within Pfizer Network or Outside as needed in a timely fashion to support the operations to comply with the expected manufacturing plans and product demand.

Role Responsibilities

• Serve as Automated Visual Inspection (AVI) equipment Subject Matter Expert (SME) in the
  development, evaluation, enhancement, and validation of critical process parameters in support of
  new, transferred and existing product lines. Has enough process and technical depth to represent
  the Company in discussions around AVI with external customers and / or auditors.
• Review and approve documentation with respective support functions to support the developed
  engineering tests, change requests and protocols as required to meet regulatory and cGMP
  requirements. Work with Automation Engineers in the development of complex equipment recipes
  to optimize product specific parameters and drive improvements as required.
• Trend and analyze performance of the equipment, uptime and process reliability indicators. Report
  to Management periodically this analysis and provide actions plans to tackle potential process shifts.
  Provide continuous improvement and anticipate issues. Provide feedback to the Line Supervisor on
  setup, cleaning, operation and training needs / practices.
• Support AVI operations in troubleshooting, training, developing procedures and process
  improvements.
• Develop long range plans for future AVI processes and systems to accommodate future growth.
• Utilize QTS for writing and supporting deviations, CAPA’s, CR’s, CI’s and other quality and regulatory
  requirements.

Qualifications

Must-Have

• PhD/JD OR:
• MBA/MBS and 1+ years' relevant experience in AVI and or Process Engineering Role:
• Bachelor's Degree and 3+ years' relevant experience in AVI and or Process Engineering Role:
• Associates Degree and 6+ years' relevant experience in AVI and or Process Engineering Role:
• 8+ years' relevant experience in AVI and or Process Engineering Role
• Knowledge of Good Manufacturing Practices and experience in Pharmaceutical environment
• Experience of project orientated admin/cost control/management
• Broad knowledge of theory and principles within a professional discipline or advanced knowledge of specific technical/operational practices
• Strong technical, management and organizational skills
• Good leadership and communication skills

Nice-to-Have

• Relevant pharmaceutical experience
• Experience in automation including DeltaV and equipment validation
• Knowledge of the manufacturing process and equipment, preferably bacterial fermentation and purification processes
• Recipe Development Experience on AVI and similar machinery

PHYSICAL/MENTAL REQUIREMENTS

• Lifting up to 25 lbs, sitting, standing, walking, bending
• Wearing gowning and personal protective equipment in specific areas
• Ability to perform mathematical calculations and ability to perform complex data analysis.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Position requires regular onsite attendance, and cannot be performed remotely. Must have the ability to work efficiently/effectively and manage strict production time and performance deadlines. Limited travel required but may include international destinations. Regular work shift but may require support off hours,
weekends or extended shifts.

Relocation assistance may be available based on business needs and/or eligibility.