What are the responsibilities and job description for the CQV Engineer - Senior Consultant/PM position at PQE Group?
Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.
Due to our constant growth, we are looking for a full-time CQV Engineer with 5 years of experience within the Lifescience / Biotech industry fitting the following mandatory skill-set and willing to work in Indianapolis, Indiana.
Responsibilities :
- Lead CQV activities for production lines with hot cell containment systems (Ampoule opening and cutting stations, Dissolution systems, Electrolysis systems, Bath circulator systems, Chromatography systems, Dry-down systems, Reconstitution systems, Waste disposal systems, Autoclave systems)
- Oversee CQV processes for recycling lines and associated subsystems (Incineration units, Precipitation systems, Tele-manipulators, Dispensing units, Ampoule sealing units, Vial leak testers)
- Conduct CQV for Controlled Temperature Units (CTUs) such as freezers, refrigerators, incubators, and other temperature-controlled equipment
- Execute CQV for facility equipment like fume hoods and pass-through units
- Coordinate with cross-functional groups to maintain CQV deliverables timeline
- Serve as an onsite resource assigned to the manufacturing facility
- Review protocols as a CQV Subject Matter Expert (SME)
- Execute approved protocols
- Generate and close all protocol deficiencies (deviations)
- Create maintenance plans within the Computerized Maintenance Management System (CMMS)
- Produce Qualification summary reports, including Summary Reports and Trace Matrices
- Generate handover release reports
- Perform risk assessments and impact analyses
- Ensure compliance with cGMP guidelines and regulatory requirements
Technical Expertise Required :
Next Steps
Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal. Alternatively, if the feedback is negative, we will contact you to halt the recruitment process.
Working at PQE Group
As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.
