Principal Engineer Technical Services - Cartridges

ROLE SUMMARY: Establish experimental protocols, conducting experiments, analyzing results, and documenting the information. Provide technical leadership in the investigations. Provide input and feedback on products and analytical methods used to characterize products. Ensure project deliverables meet their quality, safety, and functional goals, and satisfy the customer. Serving as a scientific and technical representative for 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. Reviewing/providing feedback and technical/scientific support on project deliverables. Develop technical impact assessments for all changes and develop execution plan ROLE RESPONSBILITIES: Lead scientific or engineering studies and/or investigations. Proposes process/product/device improvement opportunities and/or corrective actions to increase yield, maximize capacity, reduce costs and decrease process variability while maintaining regulatory compliance Lead changes to delivery devices together with third party and internal Pfizer sites to meet regulatory requirements. Develop risk assessments, risk mitigation strategies and risk plan. Facilitate, support, and/or execute verification of device components/system. Lead scientific studies and/or investigations. Participates on scientific and technical teams for discrepancy and investigation resolution, equipment and process validation activities, training on new analytical technologies and on significant changes to scientific procedures Keep up on scientific areas relevant to Pfizer products and analytical methodology/technology for characterizing the products.  Lead product improvement projects, or process improvements through process analytical technology. Supports change management and implementation for changes to device 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: BASIC QUALIFICATIONS BS or higher degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or related Science discipline is required.  MS or PhD degree preferred. Minimum of 5 years of experience in parenteral product pharmaceutical development/manufacturing required. Must have experience with sterile filled products/device development at large scale manufacturing facility, including method development/improving formulation or processes. Must be familiar with global regulations of products and experience with filings.  Experience with product/process/methodvalidation/qualification requirements. Demonstrated scientific and people leadership skills. Experience leading and working with teams of scientists with varying levels of experience and formal education (B.S./M.S. and/or Ph.D.) is required. Experience with cross-functional development of pharmaceutical products, including knowledge of key regulatory and quality/compliance expectations. Familiar with global regulations on devices, drugs, validation/qualification requirements. Excellent verbal/written communication skills and the ability to lead cross functional team. PREFERRED QUALIFICATIONS Competent knowledge of Empower Software or some other advanced chromatography software. Minimum of 7 years of experience in Product Development, Device Development, Engineering, pharmaceutical industry or equivalent education preferred Able to lead support staff or  interns on specific project assignments, and/or those on a rotation in the rotational development program PHYSICAL/MENTAL REQUIREMENTS No unique physical requirements Mental: Remains organized & positive in ambiguous and fast-paced, rapidly changing situations Ability to analyze data from detailed schedule and risk management tools Interface effectively with multiple stakeholder groups Ability to appropriately manage ambiguity and work autonomously Develop positive relationships with multiple manufacturing disciplines 4718620
Salary Range: NA
Minimum Qualification
5 - 7 years

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