07 Oct, 2021

Senior Process Engineer

  • Pfizer
  • McPherson, KS, USA
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

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.

 

Qualifications

 

Must-Have

  • Bachelor's Degree

  • 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

 

Nice-to-Have

  • Master's degree

  • 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

 

#LI-PFE

 

 

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.


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