Sr. Process Engineer Automated Visual Inspection (AVI)
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
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 Mfg plans and product demand.
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.How You Will Achieve It
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.
Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for short-term work activities on own projects.
Work closely with technical services to develop and confirm Critical and Key Process Parameters needed for Equipment and Process Validation.
Report team progress, highlight risks, clarify issues, suggest recommendations and present next stage development plans.
Operate process equipment, such as fermenters, recovery equipment, depth filtration equipment etc.
Coordinate, schedule & participate in daily activities of (Current) Good Manufacturing Practices (part of GxP) production in the manufacturing area to meet supply chain needs.
Facilitate effective project meetings with internal team members and with customers.
Develop SPC (Summary of Product Characteristics) charts for continuous process monitoring and control.
Develop and maintain project finances and provide information to support financial reporting requirements and cycles.
Ensure that the process adjustments are incorporated into the appropriate final version of SOPs, Master Batch Records and Compounding Records.
Provide trouble shooting and technical support to Pfizer manufacturing groups as required.
Responsible for participating in the execution of process and cleaning validations as well as related activities and projects including continued process verification.
Adhere to site safety standards, participate in routine safety training events, and enforce safety and biosafety requirements as they relate to the manufacturing department.
4+ years of experience in Pharmaceutical environment and knowledge of Good Manufacturing Practices.
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
Experience in automation including DeltaV and equipment validation
Knowledge of the manufacturing process and equipment, preferably bacterial fermentation and purification processes
OTHER JOB DETAILS:
Last day to apply: 8/17/2021
Employee Referral Bonus eligible
Relocation support available