Engineer

Duration:

12 months

Contract Responsibilities:

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 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.

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 Basic Qualifications:

Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience. Top 3

Must Have Skill Sets:

Experience with SBS paperboard Material Science Experience Experience with stack up analysis Nice to have: 3-4+ years of experience Day to

Day Responsibilities:

Package Development 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 . "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"