Parenteral Packaging Engineer
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.
The responsibilities of Scientist position include but are not limited to:
- 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 with 4-6 years of experience or Master's Degree with 2-4 years of experience 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.
Other Job Details:
- Eligible for Relocation Package: YES
- Eligible for Employee Referral Bonus: YES
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