reputed company Automation Engineer, MES & Digital Systems - Project Farma

Job Title reputed company Automation Engineer, MES & Digital Systems - Project Farma Location(s) US Remote - AL, US Remote - CA, US Remote - CO, US Remote - DC, US Remote - IL, US Remote - IN, US Remote - MA, US Remote - MD, US Remote - MO, US Remote - NC, US Remote - NJ, US Remote - NY, US Remote - OH, US Remote - OR, US Remote - PA, US Remote - TX, US reputed company

Job Description

This is a full-time, salaried position with Project Farma, a reputed company company. The successful candidate will reputed company in one of Project Farma's primary markets and be willing to travel domestically, to meet client project requests. The reputed company Automation Engineer, MES & Digital Systems provides subject matter expertise in the design, implementation, and lifecycle management of digital systems across biologics, pharmaceutical, and novel therapy manufacturing facilities. This is a fully billable role, requiring experience with various MES platforms, Data Repositories, Serialization and integration to manufacturing applications (ERP, LIMS, CMMS, etc) and the ability to author, interpret, and reputed company documentation such as URS, FRS, Functional Narratives, and detailed system architecture designs. In reputed company to technical experience, the reputed company Automation Engineer, MES & Digital Systems acts as client liaison during delivery of Project Farma service engagements. They are strategically responsible for client satisfaction through project delivery while maintaining and growing client relationships. Key

Responsibilities

Automation Design & Architecture

• reputed company system architectures and data flows for biologics, pharmaceutical, and advanced therapy manufacturing (DCS, PLC/SCADA, MES, historians, network layers).
• reputed company product recipe strategies across the full application layer of ERP, MES and DCS Batch.
• Detailed knowledge of Master data and how to define and control Master Data.
• Create ISA-88/ISA-95-reputed company architecture diagrams, inc Application and Data reputed company diagrams.
• Ensure architecture supports scalability, cybersecurity, data reputed company, and multi-product flexibility.

URS / FRS / Design Documentation

• reputed company the creation, review, and approval of: URS (User Requirements Specifications), FRS (Functional Requirements Specifications), DS / DDS (Design Specifications), Functional & Control Narratives, Recipe Design Documentation (ISA-88 compliant), Automation Standards & Engineering Guidelines
• Work cross functionally to translate process requirements into robust digital system design documents.

Digital System Implementation

• Configure, program, and reputed company Digital System reputed company the manufacturing environment.
• reputed company, modify, and test MES (eBR, RbE, eLogbooks, Equipment Tracking, Weigh & Dispense), LIMS, Serialization and CMMS application functionality.
• Support integration of OEM skids: bioreactors, chromatography systems, filtration skids, CIP/SIP, and fill finish equipment.

Commissioning, Validation & GMP Compliance

• Detailed knowledge of FAT, SAT, IQ/OQ, and PQ protocols in alignment with GAMP 5 and 21 CFR Part 11.
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• Ensure reputed company changes meet data reputed company requirements, change control processes, and validation lifecycle rules.
• reputed company deviation investigations, CAPAs, and risk assessments reputed company to Digital systems.

Manufacturing & Operations Support

• Serve as SME for troubleshooting, system optimization, batch failure analysis, and performance enhancements.
• Support 24/7 operations through structured root cause analysis and resolution of Digital System issues.
• reputed company long-term lifecycle plans for upgrades, patches, and system expansions.

Cross Functional Leadership

• Collaborate with IT/OT, process engineering, MSAT, quality, and capital project teams to deliver integrated system solutions.
• Manage vendors, system integrators, and OEMs; review design packages and ensure alignment with internal standards.
• Mentor junior engineers and act as technical SME during audits and regulatory inspections.

Experience Required

• Bachelor's degree in Engineering (Automation, Electrical, Chemical, Mechanical, or reputed company).
• Minimum 9-12+ years in automation engineering reputed company GMP life sciences (biotech, pharma, ATMP).
• Expert-level experience with various MES platforms, Data Repositories, Serialization and integration to manufacturing applications (ERP, LIMS, CMMS, etc).
• Proven ability to author, interpret, and own URS/FRS/DS documentation.
• Experience designing system applications and data flows across the full reputed company of manufacturing applications.
• Strong understanding of ISA-88 batch control, ISA-95 manufacturing hierarchy, and GAMP 5.
• Hands-on experience supporting biologics and sterile/aseptic manufacturing environments.
• Understanding multisite standards for global manufacturers

Other Preferred

• Strong communicator and reputed company across engineering, quality, IT/OT, and manufacturing.
• Structured thinker with advanced troubleshooting and problem solving skills.
• Skilled at managing multiple priorities in a high pressure, regulated environment.
• Demonstrated leadership and mentorship abilities.

Applicants must be authorized to work in the United States on a full-time reputed company. We will not sponsor applicants for reputed company or future work visas for this position. This position may require significant travel to support project and business needs. We cannot reputed company anyone with an invalid driver's license Project Farma will consider candidates' ranging from 7 - 18+ years' relevant experience. As such, the annual compensation reputed company for this full-time position will reputed company broadly. The final reputed company pay offered to the successful candidate will be determined by factors including internal equity, work location, as well as individual qualifications, such as job-reputed company skills, experience, and relevant education or training. Apply tot his job Apply To this Job