Senior AVI Process Engineer - CFF
Pfizer Inc.
McPherson, KS
Job posting number: #7136066 (Ref:pf-4880631)
Posted: March 24, 2023
Application Deadline: Open Until Filled
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 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.
Work Location Assignment: On Premise
Relocation assistance may be available based on business needs and/or eligibility.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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.
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.