Job TitleDT&A - Lead Engineer, MES & Digital Systems
Location(s)US Remote - MA
Job DescriptionThis is a
full-time salaried position withProject 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.
Project Farma's purpose is to
improve patient lives by accelerating the delivery of life-changing therapies. We accomplish this through the successful execution of high-quality life sciences projects across the full project lifecycle. Project Farma (PF) team members collaborate with cross-functional teams to build trusted client relationships, deliver an exceptional customer experience, and contribute to business growth by identifying opportunities and applying data-driven insights to support project planning, cost, schedule, and performance management.
All team members are expected to embody Project Farma's values by being
curious,
personable, and
unselfish, while maintaining a strong commitment to a
Patient Focused and People First mindset.
The Automation Engineer III and Lead Engineer is an advanced individual contributor with demonstrated depth in their technical discipline and a growing record of leading complex workstreams. This role applies strong subject-matter expertise to solve high-impact technical and operational challenges, supports technical decision-making, and contributes to the evolution of standards, methods, or best practices within their area. They partner closely with project and people leaders-while remaining focused on technical delivery rather than formal people management.
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.
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 annual compensation 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.
