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 I will work in the Device Development and Clinical Packaging
Engineering (DDCPE) organization, which provides technical leadership and expertise in the development, qualification, and
implementation of new primary, secondary, and tertiary package and drug delivery device solutions that meet the needs
of Gilead’s pharmaceutical and biologics pipeline. The selected candidate will work on a variety of packaging initiatives
and will lead the development and qualification of global packaging solutions of assigned projects. This activity
involves collaboration with Product Development Teams, Regulatory, CMO’s, Quality, Suppliers and other involved
Specific Job Requirements:
- Deliver expertise in the application of pharmaceutical packaging principles and testing methodologies
related to container closure systems.
- Develop innovative, thorough, and practicable solutions to
a wide range of difficult packaging problems.
- 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
- Support packaging operations and drive expeditious and appropriate resolution of
deviations and investigations as necessary.
- Perform characterization and qualification of primary
and secondary packaging components (e.g., bottles, blisters, vials, , caps, stoppers, labels, and britestock
- Design and write packaging study protocols and reports that support product development
and regulatory filing needs.
- Ensure compliance with international and external regulations.
- Write sections of global regulatory filings related to DDCPE activities.
- Write and
review SOPs related to DDCPE activities, ensuring alignment with other Gilead SOPs.
- Train new
employees in SOPs and documentation systems.
- Overnight travel may be required up to 25% of time.
QUALIFICATIONS: Requires a B.S. Degree in industrial engineering, mechanical
engineering, biomedical engineering, chemical engineering, package engineering, or a related scientific field and a minimum
of seven (7) years of relevant industry experience required. A Master’s Degree in industrial engineering,
mechanical engineering, biomedical engineering, chemical engineering, package engineering, or a related scientific field
and a minimum of five (5) years of relevant industry experience required. Advanced degree(s) with commensurate industry
experience are also considered. Prior experience in a cGMP-related industry is highly desirable.
Knowledge and Skills:
- Excellent technical skills and knowledge of package development principles is required. Specific
experience in the pharmaceutical/biotechnology sector is preferred.
- Expertise in the application
of pharmaceutical packaging standards (e.g., USP, ISO, ASTM).
- Knowledge of FDA and cGMP standards
- Strong verbal, written, and interpersonal communication skills are required.
- Strong computer and organizational skills are required.
- Experience collaborating with
external suppliers, contract manufacturing organizations, and contract test laboratories is desirable.
- Ability to travel up to 25% some overnight.