
Pharmaceutical Industry IT Systems Implementation Specialist
7 hours ago
IT Systems Implementation Specialist
- MES implementation specialist to support the successful integration of our manufacturing execution system with L2 systems.
- Lead validation leadership and ensure adherence to global regulations.
- Manage GxP documentation and maintain deep knowledge of MES functionality and architecture.
- Act as first point of contact for application issues and user support.
- Deliver training and ensure user readiness for MES usage.
- Support data collection, migration, and master recipe creation.
- Ensure all documentation and systems are compliant and audit-ready.
Key responsibilities include strong communication and interpersonal skills, proactive problem-solving and risk management, high attention to detail and compliance mindset, ability to work under pressure and manage multiple priorities.
- 6-8 years of experience in the pharmaceutical industry, including technical and functional experience in MES & L2 systems.
- Bachelor's degree in Engineering - Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field. A Master's degree (e.g., MBA, M.Tech, M.Pharm) with specialization in Industrial Automation, Pharmaceutical Technology or related technical fields is preferred.
- Certifications include GAMP 5 for system validation in regulated environments, CSV (Computer System Validation) for compliance with GxP, MES Platform Certifications e.g., Werum PAS-X, Siemens Opcenter, or Rockwell, and 21 CFR Part 11 Compliance Training for electronic records and signatures.
Responsibilities also include maintaining edge cloud deployment experience, L2 integration with MES, MES integration with SAP, and understanding of network and databases.
BenefitsThe ideal candidate will have additional skills in knowledge of data analytics tools and previous experience with Werum (Korber Pharma) for pharma industry.
OthersRequirements include strong communication and interpersonal skills, proactive problem-solving and risk management, high attention to detail and compliance mindset, ability to work under pressure and manage multiple priorities.
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