should have strong expertise in Siemens Opcenter Execution (Camstar), Computer System Validation (CSV), GAMP 5 methodologies, and regulated manufacturing environments.
The candidate will be responsible for planning, executing, and managing MES validation activities throughout the system lifecycle. The role includes preparing validation documentation, supporting Electronic Batch Record (EBR) implementations, conducting risk assessments, and ensuring compliance with regulatory requirements such as FDA and EU GMP standards.
Professionals should have hands-on experience with MES workflows, recipes, equipment modeling, master data management, validation testing, and system integration validation. Strong understanding of GAMP 5 Category 4/5 systems, CSV V-Model methodology, audit readiness, and quality compliance processes is highly preferred.
The role also involves collaborating with global quality teams, manufacturing sites, business stakeholders, and technical teams to support multi-site validation programs, validation testing activities, and regulatory inspections. Candidates should possess excellent documentation, communication, stakeholder management, and problem-solving skills.
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