Senior Scientist, Equipment Qualification

Senior Scientist, Equipment Qualification

Lonza

Stein, Switzerland

Lead the GMP-compliant qualification and re‑qualification of a great variety of analytical instruments and software in our QC laboratory.

What you will do:

• Lead and manage the initial qualification and re-qualification of analytical equipment and software in our QC laboratory (HPLC, CE, refrigerators etc.)
• Execution of performance qualification and act as a trainer for defined equipment and related processes
• Author, review and approve documentation (qualification plans and reports; documents from service providers) related to laboratory systems as required
• Ensure compliance of laboratory systems according to cGMP and current standard processes and regulatory guidelines as well as respective SOP`s.
• Oversight and guidance for proper maintenance and qualified state of equipment; Performing period review of qualification/calibration of analytical equipment and act as system owner for defined Equipment
• Participate as Subject Matter Expert in audits and inspections

What we are looking for:

• Solid work experience in the GMP-controlled Quality Control laboratory is a must
• Hands-on experience in qualification of analytical instruments is a must
• Apprenticeship or academical degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field
• Broad experience in analytical methodologies like e.g. HPLC, ICief, UV-VIS, Elisa, CE-SDS is an advantage. Knowledge of lab quality systems like LIMS, Tiamo or Empower/Chromeleon is a plus
• Fluency in written and spoken English is a must, Language skills in German is a plus
• You enjoy working independently and in a dynamic & fast-pacing project environment