. ROLE SUMMARY
Position will be part of Pharmaceutical Research & Development group located in Andover, MA and St. Louis MO. The incumbents will support the selection, qualification and implementation of components and container closure systems for early and late stage projects, as well as, coordinate applicable verification activities for design control projects that support the development and use of certain prefilled syringe (PFS), co-packaged and cross labeled combination products.
Work closely with vendors, PhRD and PGS SME’s in the evaluation, development, qualification and implementation of new components and container closure systems
Support the formulation and process development groups in Andover and St Louis sites to comply with regulatory requirements and guidance documents related to components and container closure systems
Author and/or review engineering and development documentation such as component drawings and specifications, assembly drawings, tolerance stack analyses, risk analyses, etc.
Participate on design control teams to author and/or review applicable design control documentation, such as design verification supporting documentation, specifications, component/device requirements and related functionality assessments, risk assessments, etc..
Facilitate, support and/or execute verification of device components and delivery systems
Bachelor's Degree or Master's Degree with 5+ years of experience with a degree in either Chemistry, Biochemistry; Biomedical, Mechanical, Materials, Chemical Engineering; or other related discipline
5+ years of relevant experience with the Pharmaceutical Parenteral Packaging Development and/or Combination Product/Device Design Control
Knowledge and/or interest in parenteral packaging, components and component testing equipment, e.g. Instron, ZebraSci, Computrac, plunger movement chamber, etc.
Knowledge of Good Manufacturing Practices (GMP)
Knowledge of packaging related regulatory standards and guidance
Knowledge of device design control associated regulatory standards and guidance
Capable of working independently with minimal supervision
High level of attention to technical details and accuracy
Being able to prioritize multiple responsibilities and to work on multiple tasks simultaneously
Demonstrated ability to work collaboratively in cross functional teams
Excellent communication (e.g. oral, written, presentation) and interpersonal relationship skills
Proficiency in general computer software such as word processing, spreadsheets, presentations
Knowledge of current US and global Regulations, US/EU/JP Compendia, ISO standards, quality system regulations (Part 4) for combination products, Container Closure Systems for Packaging Human Drugs and Biologics FDA guidance document, and other applicable FDA and ICH guidance.
Understand component selection and device design activities
Understand project management methodologies and capable to provide technical leadership for projects
Ability to perform mathematical calculations and ability to perform complex data analysis
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Approximate 10% Travel Required
Location Information: Andover MA or St Louis MO
Eligible for Relocation Package: Yes
Eligible for Employee Referral Bonus: Yes
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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.
Research and Development