This company is a research-based Bio-pharmaceutical
company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. Its goal is
to transform and simplify care for people with life-threatening illnesses around the world. Their therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious
respiratory and cardiovascular conditions. They
have over 10,000 employees and are one of the leading companies in their field.
DUTIES: The Senior Packaging Engineer II will function within the Device Development and Clinical Packaging Engineering
(DDCPE) organization, which develops primary, secondary, and tertiary package and drug delivery device solutions that
meet the needs of company’s pharmaceutical and biologics pipeline. This position will have responsibilities
in the areas of:
- Controlled Temperature Shipping Containers
and Secondary Package Development
technical leadership in the area of temperature controlled shipping containers, identifying solutions to meet stakeholder
needs, partnering with suppliers to design solutions, and executing qualification studies and authoring related reports.
Partner with stakeholders to establish infrastructure necessary to bring shipping container
solutions into service.
Lead packaging activities in support of multiple clinical programs in all phases of development,
ensuring on-time delivery of project deliverables and compliance to current Good Manufacturing Practice (cGMP).
Execute packaging equipment and process verification and validation (including IQ/OQ/PQ studies)
to prove effectiveness of new packaging configurations and/or packaging lines/sites.
packaging operations and drive expeditious and appropriate resolution of deviations and investigations as necessary.
Perform characterization and qualification of primary packaging components (e.g., bottles, blisters,
vials, prefilled syringes, caps, stoppers).
Write and review SOPs related to DDCPE activities, ensuring alignment with other Company SOPs.
Design and write packaging study protocols and reports that support product development and
regulatory filing needs.
Write sections of global regulatory filings related to DDCPE activities.
new employees in SOPs and documentation systems.
QUALIFICATIONS: Requires a Bachelor’s Degree in Packaging, industrial,
mechanical engineering, biomedical engineering or chemical engineering or a related scientific field.
Experience: A minimum of eight (8) years of relevant experience is required, OR a Master’s Degree
in industrial engineering, mechanical engineering, biomedical engineering, chemical engineering, package engineering, or
a related scientific field and a minimum of six (6) years of relevant experience.
Knowledge. Experience and Skills:
of Temperature-Controlled Shipping Containers (Cold Chain). - Very important
with (Primary and Secondary Package Development) - Very important
- Excellent technical skills and
knowledge of package development principles.
- Experience collaborating with external suppliers, contract
manufacturing organizations, or contract test laboratories is desirable.
- Detailed understanding of the
- Knowledge of FDA and cGMP standards.
- Strong verbal, written, and
interpersonal communication skills.
- Strong computer and organizational skills.
- Prior experience in a cGMP-related industry is highly desirable.
- Specific experience in the biotechnology sector is preferred.
- Some overnight travel may be required up to 25% of the time.