3key Consulting, Inc.
Senior Packaging Engineer, Biopharma, Combination Medical Device (JP14804)
3key Consulting, Inc., Thousand Oaks, California, United States, 91362
Senior Packaging Engineer, Biopharma, Combination Medical Device (JP14804)
Location:
Thousand Oaks, CA 91320
Employment Type:
Contract
Business Unit:
Manufacturing Science & Technology
Function:
Process Development / Engineering / Operations
Duration:
12 months with likely extension or conversion to permanent
Rate:
$48-52 on W2 with Benefits
Posting Date:
11/28/2025
Responsibilities
Lead development and optimization of secondary & tertiary 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 company’s 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.
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.
Top Must-Have Skill Sets
On-Site
Packaging Engineering Experience
Experience with Paper-Based Packaging
Interview Process Two interviews, possibly three — video conference.
We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our website. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.
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Thousand Oaks, CA 91320
Employment Type:
Contract
Business Unit:
Manufacturing Science & Technology
Function:
Process Development / Engineering / Operations
Duration:
12 months with likely extension or conversion to permanent
Rate:
$48-52 on W2 with Benefits
Posting Date:
11/28/2025
Responsibilities
Lead development and optimization of secondary & tertiary 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 company’s 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.
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.
Top Must-Have Skill Sets
On-Site
Packaging Engineering Experience
Experience with Paper-Based Packaging
Interview Process Two interviews, possibly three — video conference.
We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our website. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.
#J-18808-Ljbffr