Senior Analyst Manufacturing Systems – MES

Exciting opportunity for MES Analysts experienced in the Biopharma or other 21 CFR Part 11 regulated industries to take the next step in their career.

Our client helps digitally transform the operational side of their business through the implementation of Headless MES technology. Their leadership brings extensive experience in both Enterprise IT and OT and have been successful in brining modern computing platforms to the enterprise level. They are not aligned with any automation vendor and have chosen to implement only Data Hub and Headless technologies for MES applications.

The MES Analyst will have a working knowledge of ISA-95 2018, especially Parts 2 and 4, and a strong background in taking the needs of a client and transforming them into auditable User Requirements. The successful MES Analyst will work as a member of a three-man team along with a Principal Consultant and a Jr. MES Analyst.

RESPONSIBILITIES:

• Demonstrate beginning to end understanding of process flow in the Biopharmaceutical industry, especially in vaccine manufacturing.
• Interact with customer stakeholders to understand needs and develop auditable user requirements to deliver to the development team.
• Possess impeccable documentation standards and technical writing/editing skills.
• Have a relentless pursuit of self-education and a desire to learn how to implement cutting edge, containerized technology for manufacturing.
• Translate that learning into Proofs of Concept for fulfillment of the defined User Requirements.

THE SUCCESSFUL CANDIDATE WILL HAVE THE FOLLOWING KNOWLEDGE AND SKILL REQUIREMENTS:

• Bachelor’s degree in a field related to manufacturing technology preferred.
• 5+ years of experience deploying standards-driven MES platforms.
• Must have a working knowledge of 21CFR11.
• Knowledge of ISO 27001 is a plus.
• Approachable individual with good verbal and written communications skill.
• Possesses the ability to both lead and be led with an eye toward moving into a Principal role.
• Strong analytical skills
• Relentless in the pursuit of self-education
• Ability to travel as required. The role is likely to be about 10% on average with travel occurring in spurts.

To comply with some state laws, the annual base salary range for this position has been provided. The range given is broad and should be considered as a guideline only. Our client will consider a candidate’s work experience, education/training, key skills, the salaries of current employees in similar roles, and other factors when extending an offer.