Job title: Site MES Engineer
Work Location: Kalamazoo, MI
Site MES Engineer
Job Description:
The MES Integration Engineer is responsible for providing technical guidance and support in the
execution and delivery of the MES configuration at Pfizer Sites, including adherence to schedule,
engineering design (Basis of Design, Conceptual, and Detailed Design Requirements), This position
will work across multiple layers of the organisation and will liaise heavily between the Core MES team
and the Site Automation teams with the focus on delivery and oversite of MES recipes and
configuration, i.e. Electronic Batch Records (eBR), Electronic Log Books (eLogs), Equipment Tracking
(ET), and general configuration of the MES system.
An ideal candidate will have a technical background with strong business process understanding
across Manufacturing. This will includes managing the relationship with the business to evaluate
future functional enhancements and perform gap analysis as needed to meet evolving customer
requirements.
Key Accountabilities:
• Responsible for providing technical guidance and support in the execution and delivery of the
Manufacturing Execution System (MES).
• Coordinate and align within the Global MES team and other IT teams involved as well as with
the customers
• Strong experience with MES systems
• Analysis and solving of technical issues related to the MES system and/or interfaces Direct
and manage activities of technical staff on URS/FRS generation, software configuration and
coding.
• A thorough understanding of system cGMP requirements and demonstrable knowledge of
computer system design and maintenance lifecycle in cGMP environments.
• Liaise where necessary with MES platform provider, engineering contractor, and equipment
vendors on the lifecycle of document preparation, approval, coding, and delivery
• Assist with Computer Systems Validation (CSV) activities: Validation Plan, Risk Assessment,
Protocols, Test Protocols, Change Requests etc.
• General management and oversight to the MES software documentation effort
Key Requirements:
• Bachelor’s Degree in Engineering/ Technology or equivalent experience.
• A minimum of 3-5 years related work experience with factory automation and equipment
integration within the pharmaceutical sector.
• Substantial experience with design and operation of Biopharmaceutical facilities, both
manufacturing and support systems (cGMP manufacturing, pilot plant & laboratories).
• Significant experience with MES systems desirable.
• A thorough understanding of system cGMP requirements and demonstrable knowledge of
computer system design and maintenance lifecycle in cGMP environments.
• Passionate about improving the quality of software products
• Significant experience with MES systems desirable, preferably Rockwell Pharmasuite/
Emerson Syncade/ Weum PAS-X
• Experience with MES integration other Applications (ERP, preferably SAP) and Laboratory
Information Management Systems (LIMS) systems/ Historians OSISoft PI
• Understanding of system hardware design for PCS and MES
• Team player with exceptional customer service skills, integrity and ability to interact with all
levels of personnel.
• Requires strong attention to detail and analytical skills as well as problem analysis and
resolution.
• Ability to evaluate solutions and recommend action based on meeting scope, schedule, and
budget