Milestone Solutions EU is partnering with a multi-national biopharmaceutical company to support the growth of a large team of CQV Engineers for a Greenfield project based in the south of Germany. Our client is constructing a new biotechnological facility to produce pharmaceutical ingredients from cell cultures, and require a large number of engineers to assist in the Commissioning, Qualification and Validation of their equipment.
Field execution of Commissioning, Installation & Operational Qualification (IQ/OQ).
Verification for upstream/downstream process equipment, Clean utilities, Black Utilities, Clean-In-Place.
Support execution of all applicable systems as needed.
Generation and management of supporting documentation.
Assist safe start-up & field execution.
Align with CQV Lead & Lead Planner in relation to schedule creation and reporting.
Ensure Commissioning readiness of all applicable systems to support Equipment Start-up and CQV Testing.
Knowledge of recent regulations (ICH, ASTM, FDA, ISPE) and modern CQV practices.
Qualifications & Education
Ideally qualified Chemical/Mechanical/Biochemical/Biopharma Engineer, but this is not mandatory.
Minimum 3–5-year experience working as CQV engineer.
Experience in field commissioning of Black Utilities /Clean Utilities / Process Equipment USP (e.g. bioreactors, Media Prep, Media Hold, Harvest), DSP (e.g. Buffer Prep, Buffer Hold, Chroma Skids, Process Stations), Auxiliaries (Autoclaves / part washers, clean benches, etc.).
Preferred experience in commissioning using Siemens PCS7 or similar automation packages.
Preferred experience working on 2 or more Biopharmaceutical/Biotech/Pharmaceutical Projects (no packaging projects).
Experience problem solving; Team players; Field knowledge, hands-on approach (no managerial function) mandatory.
Experience in mentoring team members.
Energetic, positive, and proactive.
English language mandatory, German is an advantage but not necessary
To apply contact Kevin Cronin on +353 87 162 9928.
Email CVs to email@example.com