This full-time Senior MES Consultant/MES Lead position will provide consulting services to the biotech and pharmaceutical industries. When on a client project, the position provides the opportunity to perform development or validation activities for our OpsTrakker mobile app.
Project activities typically require a lot of personal interaction between EIS, vendors and our customers. Different projects typically require us to fill different roles, but there are three basic characteristics we are seeking: (1) very personable, (2) integrity/strong work ethic, (3) ability to quickly learn various skills. Additionally, we need people who have excellent communication skills, are great problem-solvers and can accurately analyze information to make proper decisions.
Occasional travel to customer sites is typically required. Frequency of travel varies greatly, depending on the project needs and the specific customer but likely will average 25-65%.
Responsibilities:
- 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 organization 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 team 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
- Manage and develop client relationships
- Manage medium-small teams and/or projects
Requirements:
- Bachelors• degree in Science, Engineering or relatable technical degree
- Minimum of 5 years of experience in a highly automated Pharma/Biotech manufacturing environment
- Experience with Syncade, POMSnet, PAS|X, 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
- 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
- Residence in the United States or Canada is required
