ACL Digital
Lead - US TAG @ ACL Digital | Life Sciences Recruitment
Job Title:
Packaging Engineer
Location:
Thousand Oaks, CA (Fully Onsite)
Duration:
12 months
Description:
Function:
Process Development / Engineering / Operations
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
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.
Referrals increase your chances of interviewing at ACL Digital by 2x.
Get notified about new Packaging Engineer jobs in
Thousand Oaks, CA .
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Packaging Engineer
Location:
Thousand Oaks, CA (Fully Onsite)
Duration:
12 months
Description:
Function:
Process Development / Engineering / Operations
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
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.
Referrals increase your chances of interviewing at ACL Digital by 2x.
Get notified about new Packaging Engineer jobs in
Thousand Oaks, CA .
#J-18808-Ljbffr