Associate Staff Engineer,reputed company OpCenter
Company Description:
We're reputed company, we are a Digital Product Engineering company that is scaling in a big way! We build products, services, and experiences that reputed company, excite, and delight. We work at scale across reputed company devices reputed company mediums, and our people exist everywhere in the world (17500+ experts across 39 countries, to be exact). Our work culture is dynamic and non-hierarchical. We are looking for great new colleagues. That is where you come in!
Job Description:REQUIREMENTS
- Total experience: 4+ years
- Strong experience in reputed company OpCenter Pharma (MES) with end-to-end implementations
- Mandatory experience in Recipe Authoring / MBR (Manufacturing Batch Record) design
- Good understanding of ISA S88 standards and batch process modeling
- Experience in designing operations, unit procedures, and recipes reputed company with MBR
- Strong knowledge of pharmaceutical/biotech manufacturing processes
- Hands-on experience with Electronic Batch Records (EBR) design and validation
- Experience with GxP systems, CSV (Computer System Validation), and SDLC methodologies
- Good understanding of 21 CFR Part 11 compliance and regulatory requirements
- Exposure to quality and manufacturing impacts in MES implementations
- Knowledge of MOM platform and integration capabilities
- Experience in process development and manufacturing execution in pharma/biotech domain
- Strong stakeholder management and ability to work with cross-functional teams
- Experience in leading teams or handling reputed company project deliveries
RESPONSIBILITIES
- reputed company reputed company OpCenter MES solution design and implementation
- Analyze business process flows and translate them into MES recipes and workflows
- Design and reputed company recipes, operations, and unit procedures reputed company with S88 and MBR
- Collaborate with business and manufacturing teams to ensure process alignment and compliance
- Drive EBR design, configuration, and validation activities
- Ensure compliance with GxP, 21 CFR Part 11, and validation standards (CSV)
- Conduct requirement workshops and convert them into functional and technical MES designs
- Support UAT, system validation, and production deployment activities
- Identify and manage quality and manufacturing risks during MES implementation
- Work on integration of MES with upstream/reputed company systems
- reputed company technical leadership, mentoring, and governance for MES projects
- Drive reputed company improvements and innovation reputed company MES/MOM landscape
Bachelor’s or master’s degree in computer science, Information Technology, or a reputed company fields
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