[Hiring] EU CSV Engineer @The businesses of Merck KGaA, Darmstadt, Germany

Role Description

We have an exciting new opportunity for a CSV Engineer to join us on a 12 Month Fixed Term Contract which can be fully remote in the UK or hybrid in Glasgow. In this role, you will join our project team to remotely support new infrastructure being implemented in our head office in Darmstadt, Germany. You will provide validation testing and quality expertise to ensure that the laboratory systems are installed and remain compliant to the required pharmaceutical regulations as outlined by site procedures as well as supporting audit preparation and readiness.

• Work in conjunction with onsite IT & Laboratory teams as well as the wider project groups to ensure that the site is aligned with our corporate strategy for plant digitization processes.
• Support with Development of gap analysis / action plan to address any compliance gaps identified.
• Help to determine most appropriate testing, writing protocols to be utilized for each system/integration and reporting outcomes.
• Support with the integration of existing systems into a new framework.
• Align with project timelines and report on progress.
• Flexibility with scheduling meetings as you will be working with global teams.

Qualifications

• Bachelor’s degree or above in business, Life Science, IT or engineering subject.
• Advanced knowledge of Laboratory platforms / LIMS – instrumentation and stand-alone systems.
• Work experience in regulated environments.
• Advanced knowledge of Data Integrity, GAMP / 21 CFR 11, ISO 13845.
• Knowledge of preparation of URS / FDS.
• Experienced in authoring & executing Validation protocols (IQ/OQ/PQ) and preparation of VP, VSR, SOPs, Risk Assessment.
• Knowledge of traceability matrix.
• Team Player who is result oriented with a strong affinity to transparency.