- Project Management Methodology
- Microsoft Word
- Word Processing
Position will be part of Pharmaceutical Research & Development group located at Andover, MA. The incumbents will support the selection, qualification and implementation of components and container closure systems for early and late stage projects, as well as, participate in 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
Conduct and/or assist investigations of parenteral packaging and related delivery device failures to determine root causes and work with teams to implement appropriate corrective and preventative actions
Bachelor's Degree or higher in appropriate Science & Engineering disciplines, e.g. Chemistry, Biochemistry; Biomedical, Mechanical, Materials, Chemical Engineering; or other related discipline
A minimum of 2 years relevant experience with the Pharmaceutical Parenteral Packaging Development
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
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
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.
Eligible for Relocation Package
Eligible for Employee Referral Bonus
N (Other) (United States of America)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.