Senior CQV Engineer / Senior Validation Engineer
A growing life sciences consultancy is seeking a Senior Commissioning, Qualification, and Validation (CQV) Engineer to support a high-impact biomanufacturing expansion project. This role involves hands-on work with critical process equipment and offers the opportunity to contribute to the installation, modification, and qualification of systems essential to drug substance production.
Position Overview
The successful candidate will play a key role in supporting the implementation and qualification of a chromatography skid and a product hold tank. This position requires a strong background in biomanufacturing processes and equipment, as well as the ability to work collaboratively with cross-functional teams in a regulated environment.
Key Responsibilities
- Lead or support the installation, modification, and qualification of chromatography systems and product hold tanks.
- Collaborate with Drug Substance Operations to ensure smooth turnover and integration of equipment.
- Apply industry best practices and regulatory standards to all CQV activities.
- Coordinate with engineering, operations, and quality teams to align project goals and timelines.
- Contribute to documentation and execution of qualification protocols.
Candidate Requirements
- Experience: 1-5 years of experience in drug substance biomanufacturing, with hands-on involvement in systems such as tanks, bioreactors, chromatography skids, tangential flow filtration (TFF), and single-use mixers.
- Background: Senior-level CQV Engineer or Process Engineer with validation experience.
- Preferred: Familiarity with large-scale pharmaceutical projects and prior experience with major biomanufacturing organizations.
- Location: This is a full-time, on-site role based in Bloomington, IN. Hybrid flexibility may be considered after initial onboarding and performance assessment.
- Work Authorization: Applicants must have the legal right to work in the United States without the need for current or future sponsorship.
Why Join This Team?
- Work on impactful projects that support the production of life-saving therapies.
- Be part of a collaborative, growth-oriented environment that values innovation and integrity.
- Access to professional development opportunities and a supportive team culture.
- Participate in team-building activities and employee recognition programs.
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