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

Job Title: DT&A - Lead Engineer, MES & Digital Systems

Location(s): US Remote - MA

Contract: Full-time salaried position

When joining PerkinElmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centers, providing the right solution, at the right time, to meet critical customer needs. With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and OneSource services.

This is a full-time salaried position with Project Farma, a PerkinElmer company. The successful candidate will reside in one of Project Farma's primary markets and be willing to travel domestically to meet client project requests.

Key Responsibilities

• The Automation MES & Digital Systems Engineer provides subject matter expertise in the design, implementation, and lifecycle management of digital systems across biologics, pharmaceutical, and novel therapy manufacturing facilities. This role requires deep experience with various MES platforms, Data Repositories, Serialization and integration to manufacturing applications (ERP, LIMS, CMMS, etc) and the ability to author, interpret, and lead documentation such as URS, FRS, Functional Narratives, and detailed system architecture designs.
• MES Design & Architecture Develop system architectures and data flows for biologics, pharmaceutical, and advanced therapy manufacturing (DCS, PLC/SCADA, MES, historians, network layers). Develop 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‑aligned architecture diagrams, inc Application and Data Flow diagrams. Ensure architecture supports scalability, cybersecurity, data integrity, and multi‑product flexibility.
• URS / FRS / Design Documentation Lead 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 deploy Digital System within the manufacturing environment. Develop, 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. Ensure all changes meet data integrity requirements, change control processes, and validation lifecycle rules. Lead deviation investigations, CAPAs, and risk assessments related 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. Develop 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.

Attributes for Success

• Technical Delivery: Applies advanced technical knowledge and professional expertise
• Innovation & Continuous Improvement: Seeks better ways, adapts to change and champions new ideas.
• Customer Focus & Professionalism: Represents PF with consistent professionalism, appropriate escalation and respect for internal stakeholders, even during high stress delivery situations
• Integrity & Humility: Demonstrates self‑awareness and puts PF mission above ego
• Collaboration & Communication: Communicates clearly and proactively and drives transparent alignment with clients.
• Project Execution: Delivers reliably, manages priorities and drives for high quality outcomes
• Growth Mindset: Shows openness to new ideas, feedback and change

Experience Required Education

• Bachelor’s Degree in Life Science, Engineering, or related discipline (OR a combination of equivalent work experience in capital project engineering, pharma cGMP facility start‑up, CapEx/OpEx project management and/or comparable military experience. 4+ years / 7+ years in Digital Manufacturing Systems within 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)
• Willing to travel as required for client project assignments.

Other Preferred

• Strong communicator and influencer 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.

Project Farma is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law.

PerkinElmer is committed to a culturally diverse workforce.

Applicants must be authorized to work in the United States on a full‑time basis. We will not sponsor applicants for current or future work visas for this position.

This position may require significant travel to support project and business needs. We cannot employ anyone with an invalid driver’s license.

The annualcompensation range for this full‑time position is $100,000 - 130,000. The final base pay offered to the successful candidate will be determined by factors including internal equity, work location, as well as individual qualifications, such as job‑related skills, experience, and relevant education or training.

Project Farma is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law.

PerkinElmer is committed to a culturally diverse workforce.

Are you ready to help improve the lives of millions of people and create a healthier world? When you work at PerkinElmer, that’s exactly what you’ll do. From our dedicated scientists and world‑class operations employees to our innovative R&D professionals and committed sales and service groups, we’re a unique team of 5,000+ global colleagues who come to work every day knowing we’re making a difference. Through innovation, collaboration, and believing in our mission, we strive to create an inspiring and inclusive culture for our employees, so that they can be their best and, together, create a better tomorrow. Join us today.