6 days old

Senior AVI Process Engineer

Pfizer
McPherson, KS 67460
**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 Mfg 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:**



+ Bachelor's degree in Engineering or Science discipline. Master's degree preferred.

+ 3-5 years of experience in the pharmaceutical industry preferably in a process engineering role.

+ Self-starter, team player with strong interpersonal and organizational skills. Excellent verbal and written communication skills with the ability to coach and provide guidance to others. Strong presentation skills.

+ Working knowledge of computers and software applications associated with managing spreadsheets and databases (i.e. MS Word, Excel, Power Point, etc.)

+ Proven capability in problem-solving, decision making, and application of process improvement tools.



**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



**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.



Engineering

Categories

Posted: 2020-10-13 Expires: 2020-11-12

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Senior AVI Process Engineer

Pfizer
McPherson, KS 67460

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