Remote DT&A Lead Engineer — MES & Digital Systems

PerkinElmer; Massachusetts; Hybrid; USD 100,000 - 130,000; Full time

Job summary

PerkinElmer is seeking a DT&A Lead Engineer for MES and Digital Systems. This full-time role focuses on designing and implementing digital manufacturing systems across biologics and pharmaceutical facilities, including MES architecture, data flows, and system integration with ERP, LIMS, and CMMS.

Travel to client sites is expected domestically. The candidate will lead URS/FRS/documentation, ensure compliance with GMP (GAMP 5, 21 CFR Part 11), and drive lifecycle plans for upgrades and

Qualifications

• Experience with MES platforms, data repositories, and integration to ERP, LIMS, CMMS.
• Ability to author URS/FRS/Functional Narratives and design documents.
• Knowledge of ISA-88/ISA-95 architectures and data flow diagrams.

Responsibilities

• Provide SME leadership in MES, digital system design, and lifecycle management across biologics and pharma manufacturing.
• Architect MES/DCS data flows and ensure scalability, cybersecurity, data integrity, and multi-product flexibility.
• Lead documentation deliverables (URS/FRS/Design Specs) and validation activities (FAT/SAT/IQ/OQ/PQ) per GMP.

Skills

MES platforms

Data repositories

Serialization

System integration

Documentation

Education

Bachelor's degree in Life Science or Engineering

7+ years in Digital Manufacturing Systems (GMP life sciences)

Tools

ERP

LIMS

CMMS

Job description

PerkinElmer is seeking a DT&A Lead Engineer for MES and Digital Systems. This full-time role focuses on designing and implementing digital manufacturing systems across biologics and pharmaceutical facilities, including MES architecture, data flows, and system integration with ERP, LIMS, and CMMS.

Travel to client sites is expected domestically. The candidate will lead URS/FRS/documentation, ensure compliance with GMP (GAMP 5, 21 CFR Part 11), and drive lifecycle plans for upgrades and