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Sterile Process Engineer II

ACL Digital

 

Foster City, CA, USA

Posted On: 4 days ago
Experience: 4+ years
Availability: Hybrid
Openings: 1
Category: Sterile Process Engineer
Tenure: No Preference/Any
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Description

You design, scale, and validate sterile drug product processes and container closure systems for small and large molecule parenterals.

This role is on-site.

Responsibilities

  • Develop sterile unit operations including filtration, filling, lyophilization, and vial capping.
  • Execute compatibility studies and author technical reports for container closure systems.
  • Maintain internal specifications for components like vials, stoppers, seals, and pre-filled syringes.
  • Act as the technical interface between formulation scientists and manufacturing operations.

Required Skills

  • Bachelor’s degree in Chemical Engineering, Bioengineering, Material Science, or related field (or Master’s with 2+ years experience).
  • 4+ years of industry experience in pharmaceutical parenteral formulations or sterile process engineering.
  • Proficiency in Good Laboratory Practice (GLP) for protocols and reports.
  • Knowledge of unit operations: filtration, lyophilization, and pooling/mixing.
  • Ability to write clear, concise, and error-free technical documentation.
  • Strong interpersonal and verbal communication skills.

Education

Any Graduate

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