Senior Packaging Engineer, Biopharma, Combination Medical Device (JP14804)
Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title: 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
3 Key Consulting is hiring a Senior Packaging Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description / 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 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.
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
Why is the Position Open?
Supplement additional workload on team
Top Must-Have Skill Sets:
On-Site
Packaging Engineering Experience
Experience with Paper-Based Packaging
Day to Day 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 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.
Employee Value Proposition:
Unique industry opportunity and experience.
Red Flags:
Gaps in employment
Currently resides more than 100 miles away
Multiple jobs held for less than one year
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 www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.