Principal Engineer, Component Control
Why Patients Need You
Everything 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 Achieve
As 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 It
The 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:
Qualifications
Must-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 preferred
NON-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 activities
Relocation support available
Work Location Assignment:Flexible
Last Day to Apply: 02 DECEMBER 2022
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.
Engineering
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