Senior Project Engineer (M/F/D)
Our client, a leading contract development and manufacturing organisation (CDMO), specialises in producing sterile, injectable pharmaceuticals, with a particular focus on cancer therapeutics. With a global presence, they serve more than 60 international clients from their state-of-the-art facilities
In this role, you will play a key part in managing serialisation activities across their entire network, contributing to the seamless production and distribution of life-saving medications.
Responsibilities
As a Project Engineer for Global Serialisation, you will be responsible for:
Data Flow Management: Ensuring accurate data flow across all internal and external serialisation systems.
Customer Integration: Supporting the setup of new customer connections in the Tracelink system and managing modifications to existing ones.
Process Optimisation: Driving harmonisation and standardisation of serialisation processes across all sites.
Issue Resolution: Identifying and resolving serialisation-related issues in collaboration with internal and external partners.
Master Data Management: Overseeing serial number templates and managing product and location master data within the Tracelink system.
Compliance and Validation: Maintaining the validated status of the Tracelink system through version management, in partnership with quality and CSV teams.
Audit Support: Assisting with audits and inspections related to serialization.
Counterfeit Investigation: Supporting inquiries regarding potential counterfeit products.
Documentation: Creating and updating global serialization SOPs.
Knowledge Sharing: Promoting the exchange of best practices and knowledge across teams.
Requirements
To be successful in this role, you should bring:
A degree in IT, packaging, supply chain, or a related field, or equivalent qualification.
Ideally, experience in serialization, preferably in the pharmaceutical industry.
Familiarity with global IT systems and project management experience is desirable.
Knowledge of serialization systems (e.g., Tracelink, Systech, Optel) and serialization processes.
Understanding of GMP and GDP regulations.
Strong problem-solving skills and the ability to work independently and collaboratively in an international team.
Proficiency in German and English, both written and spoken.
If interested apply today or send an email
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