Senior MES & Digital Systems Architect — GMP Life Sciences

PerkinElmer; Austin (TX); On-site; USD 140,000 - 170,000; Full time

Job summary

Project Farma seeks a seasoned Automation MES & Digital Systems Engineer to design, implement, and lifecycle-manage digital systems for biologics and pharma manufacturing. This advanced individual contributor role focuses on technical delivery rather than people management.

You will lead architecture design, URS/FRS, and documentation, integrate MES/LIMS/CMMS, and support 24/7 operations while traveling domestically as required.

Qualifications

• 10–13 years in Digital Manufacturing Systems within GMP life sciences.
• Expert-level experience with MES platforms, Data Repositories, Serialization and integration to ERP, LIMS, CMMS.
• Willing to travel domestically for client project assignments.

Responsibilities

• Develop system architectures and data flows for biologics, pharma and ATMP manufacturing.
• Create ISA‑88/ISA‑95 diagrams and align architecture with ERP, MES, and DCS.
• Lead URS, FRS, DS/ DDS, Functional Narratives and documentation.
• Configure, program, deploy Digital Systems within manufacturing environments.
• Support MES, LIMS, Serialization and CMMS functionality across sites.
• Lead validation activities (FAT, IQ/OQ, PQ) per GAMP 5 and 21 CFR Part 11.
• Collaborate with IT/OT, QA, MSAT, and capital projects; mentor engineers.

Skills

MES platforms

Data Repositories

Serialization

ERP integration

LIMS

CMMS

URS/FRS/Design Documentation

ISA-88/ISA-95 diagrams

Cybersecurity

GAMP 5 / 21 CFR Part 11

Education

Bachelor's Degree in Life Science or Engineering

Tools

ISA-88/ISA-95 architecture

Job description

Project Farma seeks a seasoned Automation MES & Digital Systems Engineer to design, implement, and lifecycle-manage digital systems for biologics and pharma manufacturing. This advanced individual contributor role focuses on technical delivery rather than people management.

You will lead architecture design, URS/FRS, and documentation, integrate MES/LIMS/CMMS, and support 24/7 operations while traveling domestically as required.