Automation Engineer - Burgwedel, Deutschland - MSD Deutschland

Beschreibung

MSD in Burgwedel (close to Hanover) is looking for a temporary Automation Engineer to strengthen their team.

Main responsibilities

• Planning, monitoring and organization of qualification and validation activities of automated systems according to cGMP specifications

• Responsible for the creation, revision and approval of GMP-relevant documents (qualification documents, SOPs) in German and English

• Collaboration in the design, procurement and commissioning of new plants in a GMP-regulated environment

• Ensuring the qualified/validated status of automated systems in the area of responsibility
• Preparation of documents for official inspections and presentation in the audit

• Leading and conducting technical investigations in the context of automation-related deviations to investigate the cause, defining suitable change & deviation management (CAPA) and following them up

• Evaluation of automated and IT systems as well as development of strategies to optimize/ensure quality and stability (e.g. through future expansions, replacements or upgrades) including identifying and implementing process and equipment improvements

Qualifications:

• Master's degree or comparable preferred (computer science, pharmacy, chemical engineering, bio technology or similar)

• At least 5 years of experience in the pharmaceutical industry or comparable experience in quality control in a GMP-regulated environment as well as experience with qualification/validation

• Experience as investigation lead, Change and Project Manager

• Experience with Siemens or comparable PLCs (Programmable Logic Controller) and HMI (Interface Software) desirable

• Very good English knowledge (technical/scientific), German proficiency is regarded a big plus.

This position is temporary (1 year), more details can be provided upon application.