CQV Engineer

Description:

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.

Responsibilities

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 kcronin@mile.ie