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.
