Senior MES Consultant/ MES Lead Remote with Travel

Enhanced Information Solutions (EIS); United States; On-site; USD 110,000 - 150,000; Full time

Job summary

Enhanced Information Solutions (EIS) seeks a Senior MES Consultant/MES Lead for the biotech and pharmaceutical sectors. The role involves leading MES design, development, and validation activities, with opportunities to work on the OpsTrakker mobile app on client projects.

The position requires strong communication, problem solving and the ability to learn rapidly, with occasional travel, typically 25–65% depending on project needs. EIS is based in Stillwater, MN, with a growing client base.

Qualifications

• Requires a Bachelor’s degree in a science or engineering field and 5+ years in a highly automated Pharma/Biotech manufacturing environment.
• Knowledge of FDA and GMP guidelines is essential.
• Experience with life sciences MES solutions and SDLC/process validation.
• Strong communication, teamwork and ability to drive meetings and actions.

Responsibilities

• Lead in the design, development, documentation, and implementation of MES.
• Design/Author/Develop/Configure Electronic Batch Records (EBR).
• Implement MES solutions and integrate with ERP and control equipment.
• Document MES configuration and validation of EBRs.
• Provide oversight for complex MES systems and collaborate with management and users.

Skills

Communication

Problem-solving

Analytical thinking

Teamwork

Meeting facilitation

Quick learning

Education

Bachelor's degree in Science/Engineering

Tools

Syncade

POMSnet

PAS|X

Camstar

Job description

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%.

EIS is a successful and very well-respected consulting company based in Stillwater, MN. We are positioned in a niche market within the pharmaceutical / biotech industries. Because demands for our services are rapidly increasing, we are entering an exciting period of growth, looking to add several resources.

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