Overview
On Site
Accepts corp to corp applications
Contract - Independent
Contract - W2
Contract - Long term
Skills
CQV
Job Details
Title: CQV Engineer
Location: Chicago, Illinois
Onsite
Key Responsibilities:
- Solid knowledge and proven experience with.
- Equipment qualification in GMP-regulated environments.
- Temperature mapping and calibration.
- Understanding of GAMP5 principles.
- Good documentation practices (GDP).
- Capability to handle multiple systems in parallel, following a risk-based approach to prioritize tasks.
- Experience in authoring and reviewing validation protocols and reports, including deviation management.
Required Qualifications:
- 3-5+ years of experience in commissioning, qualification, and validation in regulated pharmaceutical or biotech manufacturing settings.
- Familiarity with electronic validation/document management systems such as Kneat.
- Proficiency with lab validation equipment including Ellab for thermal mapping and filter integrity testing.
- Strong communication and organizational skills with the ability to lead cross-functional discussions and manage timelines.
- In-depth understanding of change control, deviation handling, and regulatory compliance in GMP environments.
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