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Principal Engineer, Component Control

Company: Pfizer
Location: Lake Forest
Posted on: November 22, 2022

Job Description:

Why Patients Need YouEverything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk based compliant quality culture is flexible, innovative and customer oriented. Whether you are involved in development. maintenance, compliance and or analysis, your contributions will directly impact patients.What You Will AchieveAs the Principal Engineer, Component Control, you will focus on primary packaging components specifically pre-filled syringe (PFS) presentations used across our network. You will be creating risk based target specifications, developing strong suppliers partnerships and providing network support on investigations associated with these components. You will also be developing Proof of Concept (POC) and development strategies and executing experiments in the laboratory environment. As the PFS Subject Matter Expert (SME), you will provide training on various tools, and facilitate technical and continuous improvement programs with the Pfizer operational sites to ensure line compatibility. With global procurement, you will ensure alignment with overall business relationships and suppliers to improve the total cost of quality. You will also leverage existing co-development processes with R&D to ensure product suitability and compatibility.You will ensure continuity of supply by driving toward zero defects on primary container components through continuous improvement for both Pfizer manufacturing and supplier processes. You will provide packaging knowledge on large projects with large multi-discipline teams impacting many products or full product lines including assisting with defining the technical strategy, and provide support on investigations related to primary packaging containers.How You Will Achieve ItThe Principal Engineer specializing in PFS will provide scientific expertise and leadership to drive global strategies that improve component quality, supply reliability and total cost of ownership for Sterile Injectables and delivery system components. The primary function of this role is provide safe and functional product to US and Global markets through the following activities:

  • Serve as technical owner for PFS components, materials and technologies and provide expertise as a key technical representative for product related issues that can have significant business impact
  • Assist with technical expertise on complex component / material investigations
  • Assist with defining strategic direction for product portfolio as a result of internal or external change
  • Lead and support technical initiatives and design risk-based primary packaging systems for new product launches and change projects
  • Develop Prove of Concept (POC) and development strategies and support the execution of experiments in the laboratory environment
  • Interface directly with Suppliers on product/process changes that impact multiple portfolios to define the best solution for Pfizer
  • Develop strategic technical packages for global scale package changes to support process improvements in manufacturing operations worldwide
  • Assist with strategic direction on portfolio-wide product changes to support guidance changes
  • Serve as product technical representative for Regulatory to develop portfolio strategies
  • Provide industry direction to align with Pfizer strategies by participating externally on committees / forums / etc. -Additional skills / responsibilities:QualificationsMust-Have
    • Bachelor's Degree with 5+ years of experience in pharmaceutical production, support of Pharmaceutical products or closely related field OR
    • Master's Degree with 3+ years of experience in pharmaceutical production, support of Pharmaceutical products or closely related field OR
    • PhD with 2+ years of experience in pharmaceutical production, support of Pharmaceutical products or closely related field
    • Experience must be in production or support of parenteral products or a closely related field
    • Demonstrated ability to provide product knowledge on strategic projects with large multi-discipline teams impacting product portfolios
    • Demonstrated ability to perform as a technical leader when interfacing with all areas of Pfizer's manufacturing network and auditors/inspectors
    • Ability to provide sound decisions with regard to product function, specifications, plant/equipment design and function, and providing the scientific and technical basis to approach and solve problems
    • Excellent technical writing, organizational and problem solving skills
    • Ability to perform complex data analysis
    • Capable of understanding the product function, specifications, and plant/equipment design and function
    • Ability to provide the scientific and technical basis to approach and solve problems
    • Ability to develop and execute POC / Developmental laboratory studies and interpret the results -Nice-to-Have
      • Mechanical, Biomedical or Chemical Engineering field of study is preferredNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Non-Standard Work Schedule, Travel, or Environment Requirements
        • Occasional and international travel will be required to provide on-site technical support, visit supplier and Pfizer sites and address issues across the network
        • Adherence to safety procedures and use of appropriate personal protective equipment will be critical for laboratory work on site visits
        • Occasional non-core/non-standard work hours may be required to support meetings in different regions or in support of critical activitiesRelocation support availableWork Location Assignment: -FlexibleLast Day to Apply: 02 DECEMBER 2022Relocation 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 ActPfizer 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 EligibilityPfizer 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#LI-PFE

Keywords: Pfizer, Lake Forest , Principal Engineer, Component Control, Engineering , Lake Forest, California

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