CQV Downstream Lead
Job Location:
Limerick, PA - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
CAI Overview
Are You Ready
About Us
CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach field-tested processes and elite expertise developed over 30 years.
About the Role
We are hiring a CQV Downstream Lead to manage commissioning and qualification activities across downstream process systems on a major biopharmaceutical manufacturing project.
This is a high-visibility leadership role where you will own downstream CQV delivery from system design review and risk assessment through execution qualification (IQ/OQ/PQ) and handover to Operations.
Responsibilities
- Lead end-to-end CQV for downstream systems (design IQ/OQ/PQ handover)
- Own downstream technologies: chromatography UF/DF/TFF filtration CIP/SIP
- Drive system readiness: walkdowns punch lists FAT/SAT startup
- Execute risk-based CQV strategy (GMP Annex 15 ASTM E2500)
- Lead IQ/OQ/PQ execution and ensure right-first-time delivery
- Oversee CQV documentation (plans risk protocols reports)
- Manage deviations change control CAPAs inspection readiness
- Coordinate across Engineering QA Automation Ops Vendors
- Lead and mentor CQV team members
- Degree in Engineering Biotechnology or related
- 7 years CQV experience in biopharma (strong downstream focus
- Experience with CQV documentation deviations change control
- Strong stakeholder and on-site leadership skills
Preferred
- Experience leading CQV on large capital projects
- Knowledge of downstream purification (capture polish viral filtration)
- Exposure to single-use systems skids or automation interfaces
- Experience supporting audits / inspections / operational readiness
Whats In It For You
- Lead high-impact downstream CQV delivery on a flagship biologics project
- Work with cutting-edge purification technologies and systems
- Join a high-performing CQV team on complex large-scale builds
- Gain strong visibility with clients and senior project stakeholders
- Exposure to end-to-end project lifecycle
About Company
CAI helps organizations leverage technology, people, and processes to solve business problems, enable savings, and spur innovation.
