Pfizer Senior Principal Process Engineer in McPherson, Kansas

ROLE SUMMARY:

  • Manage changes to products or processes together with third party and internal Pfizer sites to meet regulatory requirements.

  • Develop risk assessments, risk mitigation strategies and risk plan.

  • Establish experimental protocols, conducting experiments, analyzing results, and documenting the information.

  • Provide technical leadership in the investigations of delivery system failures to determine root cause and implement appropriate corrective and preventive actions.

  • Ensure project deliverables meet their quality, safety, and functional goals, and satisfy the customer.

  • Serving as a scientific and technical representative for product- and process-related issues at the facility.

  • Partnering with manufacturing to meet the production schedule, ensure commercial supply , uphold quality standards and driving towards zero defects

  • Performing trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift.

  • Identifying and implementing potential process improvements in conjunction with manufacturing operations.

  • Participating in start-up efforts of new equipment, software or processes in manufacturing.

  • Assisting in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes.

  • Reviewing/providing feedback and technical/scientific support on project deliverables, i.e. remediation initiatives, plan reports, etc.

  • Develop technical impact assessments for all changes and develop execution plan.

ROLE RESPONSBILITIES:

  • Participates on technical team for discrepancy and investigation resolution, equipment and process validation activities, training on new process technologies and on significant changes to manufacturing procedures

  • Proposes process/product improvement opportunities and/or corrective actions to increase yield, maximize capacity, reduce costs and decrease process variability while maintaining regulatory compliance.

  • Provides technical support for equipment and process validation activities conducts process overview training to support implementation of new process technologies and assists in defining the scope of capital projects.

  • Leads process/product improvements, creates data packages by justifying and outlining recommendations for changes to or improvements in production processes and collaborates with technical staff to implement process technology initiatives.

  • Supports change management and implementation for changes to products or the associated manufacturing processes and associated systems, provides training for technical staff on these changes.

  • Executes laboratory runs and writes technical reports summarizing laboratory results, generating necessary lab data to support product impact assessments during discrepancies and investigations.

QUALIFICATIONS:

  • BS, MS or higher degree in Mechanical, Chemical, or Industrial Engineering or relates Science is required. PhD degree preferred.

  • Minimum of 7 years of experience in parenteral pharmaceutical product development and/or manufacturing required.

  • Must have extensive knowledge with the manufacture of products at large scale manufacturing facility. Prefer this experience includes development/improving of cartridge or pre-filled syringe manufacturing processes and/or product development.

  • Must be familiar with global regulations of products and experience with filings.

  • Experience with product/process/method validation/qualification requirements.

  • Demonstrated scientific and people leadership skills. Experience leading teams of scientists with varying levels of experience and formal education (B.S./M.S. and/or Ph.D.) is required.

  • Experience defining and implementing control strategies for manufacturing processes.

  • Experience with cross-functional development of pharmaceutical products, including knowledge of key regulatory and quality/compliance expectations.

  • Excellent verbal/written communication skills and the ability to lead cross functional team.

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.

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.

Other Job Details:

  • Last Date to Apply for Job: December 31, 2018Eligible for Relocation Package

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.