Senior Packaging Engineer, Biopharma, Combination Medical Device (JP14804)

Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 2, 2026

Job Description:

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. Regards, 3KC Talent Acquisition Team

Keywords: 3 Key Consulting, Newport Beach , Senior Packaging Engineer, Biopharma, Combination Medical Device (JP14804), Engineering , Thousand Oaks, California