Pharma Automation and Controls Engineer

PerkinElmer

. Develop system architectures and data flows for biologics, pharmaceutical, and advanced therapy manufacturing systems .

Posted 9/29/2026full-timeUnited StatesJuniorMid-Level💰 $60,000 - $180,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing system architectures and data flows for biologics and pharmaceutical manufacturing, with a strong focus on MES, LIMS, and ERP integration. Proven ability to lead documentation efforts and ensure compliance with industry standards such as ISA-88 and ISA-95.

Highest-signal resume keywords

Expert-Level Experience With MES PlatformsStrong Understanding Of ISA-88 Batch ControlProven Ability To Author URS/FRS/DS DocumentationHands-On Experience In Biologics ManufacturingExperience With GMP Validation Activities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

System Architecture DevelopmentData Flow DesignRecipe Design DocumentationAutomation StandardsBatch Application ConfigurationTroubleshooting And OptimizationRoot Cause AnalysisRisk AssessmentGMP ComplianceDigital System Design

Soft Skills

Mentoring Junior EngineersClient LiaisonCollaboration With Cross-Functional Teams

Tools & Technologies

MESLIMSERPCMMSSerializationData RepositoriesISA-88ISA-95GAMP 5

Industry Keywords

BiologicsPharmaceuticalAdvanced Therapy ManufacturingGMP Life SciencesAseptic ManufacturingMultisite Standards

Tech Stack

Tools & technologies

Cyber SecurityERP

About the role

Key responsibilities & impact

Develop system architectures and data flows for biologics, pharmaceutical, and advanced therapy manufacturing systems
Develop product recipe strategies across ERP, MES, and DCS Batch application layers
Define and control master data
Create ISA-88/ISA-95-aligned architecture and application/data flow diagrams
Ensure architecture supports scalability, cybersecurity, data integrity, and multi-product flexibility
Lead creation, review, and approval of URS, FRS, DS/DDS, functional and control narratives, recipe design documentation, automation standards, and engineering guidelines
Translate process requirements into digital system design documents
Configure, program, deploy, modify, and test MES, LIMS, Serialization, and CMMS functionality
Support integration of OEM skids and manufacturing equipment
Support FAT, SAT, IQ/OQ, and PQ protocols and GMP validation activities
Lead deviation investigations, CAPAs, and risk assessments related to digital systems
Troubleshoot, optimize, and analyze batch failures and system performance
Support 24/7 operations through root cause analysis and issue resolution
Develop lifecycle plans for upgrades, patches, and system expansions
Collaborate with IT/OT, process engineering, MSAT, quality, and capital project teams
Manage vendors, system integrators, and OEMs; review design packages
Mentor junior engineers and act as technical SME during audits and regulatory inspections
Act as client liaison, supporting client satisfaction, project delivery, and client relationships

Requirements

What you’ll need

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 ERP, LIMS, CMMS, and other manufacturing applications
Proven ability to author, interpret, and own URS/FRS/DS documentation
Experience designing system applications and data flows across 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 of multisite standards for global manufacturers
Applicants must be authorized to work in the United States on a full-time basis
Applicants must be able to work without current or future visa sponsorship
Cannot employ anyone with an invalid driver's license
Willingness to travel domestically and potentially significantly for project and business needs

Benefits

Comp & perks

Equal opportunity and culturally diverse workforce commitment
Significant domestic travel opportunities/support for project and business needs