Senior Packaging Engineer, Biopharma, Combination Medical Device (JP14804) at 3 Key Consulting

Job Title:Senior Packaging Engineer Biopharma Combination Medical Device (JP14804)Location:Thousand Oaks CA. 91320Employment Type: ContractBusiness Unit:Manufacturing Science & TechnologyFunction: Process Development / Engineering / OperationsDuration:12 months with likely extension or conversion to permanentRate: $48-52 on W2 with BenefitsPosting Date:11/28/20253 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 packagingDevelop and execute packaging test protocols including:Transportation simulation (ISTA/ASTM)Aging and shelf-life studiesCold-chain and environmental conditioningPackaging line engineering studiesEnsure 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 Companys 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:Masters degree in Engineering or related field.Experience with combination products injection devices and cold-chain distribution systems.Knowledge of paperboard structural design & FEAWhy is the Position OpenSupplement additional workload on teamTop Must-Have Skill Sets:On-Site Packaging Engineering ExperienceExperience with Paper-Based PackagingDay to Day ResponsibilitiesLead 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 studiesCold-chain and environmental conditioningPackaging line engineering studiesEnsure 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 companys 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 employmentCurrently resides more than 100 miles awayMultiple jobs held for less than one yearInterview process:Two interviews possibly three - video conferenceWe invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this position please feel free to take a look at the other positions on our You are welcome to also sharethis opportunity withanyone you think might be interested in applying for this role.Regards3KC Talent Acquisition TeamRequired Experience:Senior IC Key Skills Continuous Integration,Food Industry,Minitab,Packaging,CAD,Mechanical Knowledge,Plastics Blow Molding,SolidWorks,Mechanical Engineering,Plastics Injection Molding,Microsoft Project,Manufacturing Experience: years Vacancy: 1 Monthly Salary Salary: 48 - 52