- Lead in the design, development, documentation, and implementation of Manufacturing Execution Systems (MES)
- Design/Author/Develop/Configure Electronic Batch Records (EBR)
- Implement MES solutions and integrate with ERP and control equipment
- Documentation of MES configuration and validation of EBRs
- Provide organisation oversight for complex systems involving the development of MES
- Work closely with business management and users to strategically define the needs and design solutions that add value
- Partner with business clients and delivery teams to determine appropriate solutions
- Direct the activities of teams in the above tasks
- Document and analyze the information needs of the business and ensure appropriate solutions are delivered
- Gather user requirements in relation to controlling and recording manufacturing activities
- Respond to requests for client proposals
- Manage and develop client relationships
- Global System Implementation
- Manage medium to large teams and/or Projects
- Bachelors’ degree or equivalent experience
- Minimum of 7 years of experience in a highly automated Life Sciences manufacturing environment
- Experience with PAS|X, Syncade, PharmaSuite, XFP, POMS, Camstar or other life sciences compatible MES solutions
- Knowledge of FDA and GMP guidelines a must
- Working knowledge of software Development Life Cycle (SDLC) and support methodologies required
- Understanding of Life Sciences validation processes required
- Bachelors’ degree in Science, Engineering or relatable technical degree
- Strong written and oral communication skills needed
- Ability to work in a team-oriented, collaborative environment
- Ability to facilitate meetings and follow up with resulting action items
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Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process.
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