Manufacturing Execution Systems Engineer

AM Technical Solutions- Who Are We:

AM Technical Solutions (AM), founded in 1994, is a proven and licensed architecture, engineering, and construction firm bringing innovative solutions to the Biopharma industry to help in the fight to save lives. Our knowledge and expertise in high-tech spaces combined with our culture-first mentality allows our team to deliver the entire scope of work for high-tech construction projects on schedule, on budget, and at the level of quality required by customers. AM Life Science being an integrated part of AM Technical Solutions brings new energy and ideas to an ever-changing industry. Our team is comprised of motivated, intelligent, capable and qualified individuals who design, execute and manage projects and programs that implement risk-based approaches utilizing scientific data and justifications to align with the regulatory and industry standards. AM Life Science takes pride in our accuracy, efficiency, and integrity, which translates into cost and time savings for our Clients.

Job Title: Manufacturing Execution Systems (MES) Engineer

Current Locations: Portsmouth, NH, Framingham, MA

Position Description

AM is looking for a Manufacturing Execution Systems (MES) Engineer to join our organization to support manufacturing processes for a GMP facility. This Engineer will work on developing new Electronic Batch Records (eBRs) and revising existing eBRs using a library of existing work instructions and operations. This person is expected to operate with some supervision and some autonomy. We are looking for an engineer with a background in implementing or software engineering for MES systems (ex.- weigh and dispense, EBR, integration), preferably in a regulated or pharmaceutical production environment. They should have an understanding of TrackWise, SAP, and LIMS, and experience with automated systems such as Delta V.

Direct Involvement Opportunities:

• Develop new electronic batch records (eBRs) and revising existing eBRs using a library of existing work instructions and operations.
• Work with RA supervisor to monitor progress against a known schedule.
• Create new electronic workflows as assigned. Incorporate identified changes from the recipe review process.
• Execute protocols for testing and validation of eBRs, operations and electronic work instructions.
• Assist senior staff in the execution of Process Change Controls and responses to CAPAs.
• Conduct troubleshooting on eBRs and Syncade development environment.
• Support the approval and roll-out of new/revised SOPs as part of paper BRs to eBRs conversion and any ongoing process improvements.
• Off-hours coverage and support responsibility via a rotating schedule.

Qualifications, Skills, And Experience:

• Bachelors Degree required. Preferred area of study in Engineering, Biology, Chemistry, or similar.
• Excellent communication, client consulting, and project management skills.
• A core background in either Life Sciences Manufacturing or MES (Manufacturing Execution Systems) with complementary skills in the other. Preferred experience in an IT Engineering role supporting manufacturing or related industry.
• Core Computer IT Skills and capability to learn advanced IT skills, with Beginner to Intermediate knowledge of one or more of the following: SQL Server; Oracle; Windows Server; Crystal Reports; Windows 7/8/10 (power user or admin); Networking; Software/Testing Lifecycle; Microsoft Team Foundation Server; Javascript or Typescript.
• Experience with Emerson Syncade platforms.
• Background in implementing or software engineering for MES systems (ex.- weigh and dispense, EBR, integration), preferably in a regulated or pharmaceutical production environment.
• Understanding of TrackWise, SAP, and LIMS.
• Experience with automated systems desired (Delta V Preferred).
• Hardworking, inquisitive, mentally flexible, and critical thinking are must-have qualities for the role.
• Ability to maintain a professional demeanor at all times.
• A positive attitude and an ability to adapt to, and embrace changed conditions are a big plus.

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