Pharma Automation & Controls Engineer - Project Farma

PerkinElmer; Raleigh (NC); On-site; USD 60,000 - 180,000; Full time

Job summary

Project Farma is seeking a DT&A Engineer with 2+ years to 16+ years of automation experience in GMP life sciences. The role requires designing and implementing digital systems across biologics and pharma facilities, with heavy emphasis on MES, ERP, LIMS, and CMMS integrations.

The engineer will liaise with clients during delivery, ensuring project satisfaction and long-term relationships. Domestic travel to meet client requests is expected.

Qualifications

• Bachelor’s degree in Engineering (Automation, Electrical, Chemical, Mechanical, or related).
• 2–16+ years in automation engineering within GMP life sciences (biotech, pharma, ATMP).
• Expert-level experience with 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 spectrum 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

Responsibilities

• Automation design & architecture for DCS, MES, and related systems.
• Develop data flows and product recipe strategies across ERP, MES, and DCS Batch.
• Lead URS/FRS/Design Documentation creation and approvals.
• Configure, program, and deploy Digital System within manufacturing environment.
• Support MES, LIMS, Serialization and CMMS functionality.
• Lead validation activities (FAT/SAT/IQ/OQ/PQ) per GMP and data integrity rules.
• Collaborate with IT/OT, process engineering, MSAT, quality, and capital project teams to deliver integrated solutions.
• Mentor junior engineers and act as SME during audits and regulatory inspections.

Skills

MES platforms

Data repositories

Serialization

ERP integration

LIMS integration

CMMS integration

ISA-88 / ISA-95 knowledge

GAMP 5 understanding

Education

Bachelor’s degree in Engineering

Tools

URS/FRS documentation

Job description

Project Farma is growing our Digital Tranformation & Automation (DT&A) practice, and will consider candidates' ranging from 2 - 16+ years' relevant experience. The successful candidate will reside in one of Project Farma's primary markets and be willing to travel domestically, to meet client project requests.

• Market locations include but are not limited to: Boston, Philadelphia, DMV, Northern New Jersey, Chicago, Indianapolis, Columbus, St Louis, Kansas City, Raleigh-Durham, Houston, Dallas, Boulder, Portland, San Francisco, San Diego, and Los Angeles.

The Digital Transformation & Automation (DT&A) Engineer 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 lead documentation such as URS, FRS, Functional Narratives, and detailed system architecture designs.

In addition to technical experience, the DT&A Engineer 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

• 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.
• 2/2
• 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.

Experience Required

• Bachelor’s degree in Engineering (Automation, Electrical, Chemical, Mechanical, or related).
• Minimum 2-16+ years in automation engineering 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).
• Proven ability to author, interpret, and own URS/FRS/DS documentation.
• Experience designing system applications and data flows across the full spectrum 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 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 Farmais 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 $60,000 - $180,000. The final base pay offered to the successful candidate will bedeterminedby factors including internal equity, work location, as well as individual qualifications, such as job-related skills, experience, and relevant education or training.