CQ Engineer
- Germany, Frankfurt
- Contract
- Life Sciences
This is a fantastic opportunity for a CQ Engineer to join our major, global pharmaceutical client on their latest new-build project based in Frankfurt, this is a large-scale greenfield capital project and investing more than $1bn.
What you'll do:
- Develop and execute URS, DQ, IQ, OQ, PQ protocols for lab equipment and systems
- Perform risk assessments to determine qualification scope and criticality
- Lead commissioning activities, including FAT/SAT coordination with vendors
- Ensure GMP compliance and alignment with ISPE Baseline Guides, Annex 15, and FDA 21 CFR Part 211
- Collaborate with QA, Lab Managers, and IT to validate software-controlled instruments (e.g., LIMS, CDS)
- Bachelor’s degree in Engineering, Life Sciences, or related field
- Requires extensive experience in CQV within pharma or biotech
- Strong understanding of GxP, CSV, and GAMP 5 principles
- Experience qualifying lab instruments such as HPLC, GC, UV-Vis, TOC, centrifuges, incubators
- Proficiency in writing and executing qualification protocols
- Familiarity with electronic documentation systems and validation lifecycle
- Excellent communication and cross-functional collaboration skills
#LI-CO1
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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Caroline
I manage this role.