Engineer, Quality Engineering
Job in
Thousand Oaks, Ventura County, California, 91360, USA
Listed on 2026-06-02
Listing for:
ACL Digital
Full Time
position Listed on 2026-06-02
Job specializations:
-
Engineering
Quality Engineering, Packaging Engineer, Manufacturing Engineer, Biomedical Engineer
Job Description & How to Apply Below
Thousand Oaks, CA Fully Onsite - Standard Hours
Function:
Process Development / Engineering / Operations
________________________________________
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:
o Transportation simulation (ISTA/ASTM)
o Aging and shelf-life studies
o Cold-chain and environmental conditioning
o 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 Client 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.
* Ability to work onsite at Client's Thousand Oaks campus.
________________________________________
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
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×