REQUIREMENTS
- 9 years of experience in Pharma / Biotech MES implementations
- Hands-on experience with Siemens Opcenter and recipe authoring (mandatory)
- Experience in EBR design MBR development and S88 standards
- Strong knowledge of GxP CSV and 21 CFR Part 11
- Understanding of pharmaceutical manufacturing processes and biotechnology products
- Experience in validation activities (IQ OQ PQ RTM) risk and gap analysis
- Exposure to MES integrations and solution architecture
- Strong communication documentation and stakeholder management skills
- Experience leading teams or complex projects is preferred
RESPONSIBILITIES
- Conduct discovery workshops requirement gathering and process analysis
- Design recipes workflows and Electronic Batch Records (EBR) aligned with MBR and S88
- Execute dry runs testing and validation before Go-Live
- Support MES implementation integrations and production issue resolution
- Prepare and manage validation plans and documentation
- Participate in audits compliance activities and cGMP requirements
- Support solution design integrations and system configurations
- Troubleshoot issues during testing validation and deployment
Qualifications :
Bachelors or masters degree in computer science Information Technology or a related field
Remote Work :
No
Employment Type :
Full-time
REQUIREMENTS9 years of experience in Pharma / Biotech MES implementationsHands-on experience with Siemens Opcenter and recipe authoring (mandatory)Experience in EBR design MBR development and S88 standardsStrong knowledge of GxP CSV and 21 CFR Part 11Understanding of pharmaceutical manufacturing pro...
REQUIREMENTS
- 9 years of experience in Pharma / Biotech MES implementations
- Hands-on experience with Siemens Opcenter and recipe authoring (mandatory)
- Experience in EBR design MBR development and S88 standards
- Strong knowledge of GxP CSV and 21 CFR Part 11
- Understanding of pharmaceutical manufacturing processes and biotechnology products
- Experience in validation activities (IQ OQ PQ RTM) risk and gap analysis
- Exposure to MES integrations and solution architecture
- Strong communication documentation and stakeholder management skills
- Experience leading teams or complex projects is preferred
RESPONSIBILITIES
- Conduct discovery workshops requirement gathering and process analysis
- Design recipes workflows and Electronic Batch Records (EBR) aligned with MBR and S88
- Execute dry runs testing and validation before Go-Live
- Support MES implementation integrations and production issue resolution
- Prepare and manage validation plans and documentation
- Participate in audits compliance activities and cGMP requirements
- Support solution design integrations and system configurations
- Troubleshoot issues during testing validation and deployment
Qualifications :
Bachelors or masters degree in computer science Information Technology or a related field
Remote Work :
No
Employment Type :
Full-time
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