Job Description

Project Overview:
We are seeking a highly motivated Commissioning & Qualification (C&Q) Engineer to support a molecule tech transfer within a new SUT (Single-Use Technology) building. This role will be critical in the introduction and qualification of new equipment to support drug substance (DS) manufacturing. The C&Q Engineer will report to the site C&Q Lead and work cross-functionally with stakeholders across SUT

Key Responsibilities:

• Execute commissioning and qualification activities for new process equipment.
• Author and execute IOQ protocols aligned with and regulatory standards.
• Support equipment FAT/SAT, walkdowns, and system integration testing.
• Collaborate with cross-functional teams, including process engineering, validation, QA, and manufacturing.
• Ensure proper documentation and tracking within Valgenesis

This is a Contract role for up to 9 months - up to $68/hr commiserate to experience

Requirements

Required Qualifications:

• 8+ years of experience in commissioning and qualification, ideally within biopharma.
• Strong background in single-use process equipment and tech transfer environments.
• Self-driven and adaptable, with strong communication and documentation skills.
• Local to San Diego (Oceanside area) and available for onsite support.
• Familiarity with Valgenesis is a plus.

Preferred Skills and Experience:

• Experience with upstream and downstream single-use systems, such as:
• Single-Use Bioreactors (SUBs)
• Media/buffer prep systems and mixers
• Chromatography and TFF systems
• Sterile filtration and depth filtration skids
• Single-use manifolds and wave bioreactors
• Familiarity with automation platforms (e.g., Emerson DeltaV, Rockwell)
• Prior involvement in:
• Vendor FAT/SAT support
• Equipment walkdowns
• IOQ documentation
• System integration testing
• Experience in environments requiring rapid changeovers and flexible production setups.

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