"Alerted.org

Duration: 12 months contract

Shift:** **Regular working hours

Job Description:

+ Lead development and optimization of secondary & tertiary packaging packaging for biologics, sterile injectables, and combination products (e.g., prefilled syringes, autoinjectors).

+ Create and maintain component specifications for vials, stoppers, syringes, seals, cartons, labels, and distribution packaging.

+ Develop and execute packaging test protocols including: Transportation simulation (ISTA/ASTM), Aging and shelf-life studies, Cold-chain and environmental conditioning and Packaging line engineering studies

+ Ensure compliance with global regulatory expectations (FDA, EMA, ISO 11607, USP).

+ Prepare and review packaging documentation for regulatory submissions.

+ Support tech transfer, scale-up, and readiness activities at manufacturing sites and CMOs.

+ Lead investigations for packaging deviations, component failures, and operational issues; drive CAPA and continuous improvement.

+ Partner with suppliers and Procurement to qualify components, assess supplier capability, and manage change notifications.

+ Represent Packaging Engineering on cross-functional project teams, ensuring alignment with design control and DHF requirements.

Basic Qualifications:

+ Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Materials Science, Chemical Engineering, Biomedical Engineering, or related field.

+ 7+ years of packaging engineering experience in biopharmaceutical, pharmaceutical, or medical device environments.

+ Strong understanding of cGMP, sterile product packaging, and biologics/combination product considerations.

+ Experience with packaging validation and ISTA/ASTM distribution testing.

+ Excellent communication skills and ability to collaborate across functions.

+ Ability to work onsite at Thousand Oaks campus.

Preferred Qualifications:

+ Master’s degree in Engineering or related field.

+ Experience with combination products, injection devices, and cold-chain distribution systems.

+ Knowledge of paperboard, structural design & FEA

Must Have Skill Sets:

+ Packaging Engineering Experience

+ Experience with Paper-Based Packaging

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com .

"US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"