OT Program Specialist : Raleigh, NC

OT Program Specialist

Location: Raleigh, NC

Introduction
This role is intended to support a Program Director responsible for leading the
implementation of Electronic Batch Records (EBR) across biopharma USA
manufacturing sites, as well as managing a Quality Analytics Program focused on
improving compliance, visibility, and operational performance through datadriven
insights.
The position will work closely with the Program Director and OT global team to provide
handson support for the implementation of EBR solutions and
quality/manufacturing analytics projects within a regulated biopharma environment.
The role will actively contribute to the delivery of EBR/eDHR, MES, and analytics
capabilities, bridging manufacturing operations, Quality, Engineering, and IT.
The individual is expected to bring practical, ontheground experience in
GxPregulated manufacturing environments, supporting system implementation,
validation/assurance activities, and data integrity requirements. A key aspect of the role
is translating programlevel strategy into sitelevel execution, ensuring consistent
adoption, compliance, and operational effectiveness.
This position will collaborate with distributed teams across the United States and
Europe, primarily Spain and GWWO, and will play a critical role in enabling crosssite
alignment and execution across regions.

Skills required to perform the role effectively in a regulated biopharma manufacturing
environment.
OT + Manufacturing domain knowledge
Familiarity with Industrial automation fundamentals (PLC, DCS, SCADA, HMI;
ISA-88/ISA-95 concepts)
Manufacturing operations understanding (batch vs. continuous, OEE, downtime,
yield, scrap)
Familiarity with Quality execution processes (deviations, CAPA, nonconformance,
inspections, genealogy/traceability)
Familiarity with MES/MOM concepts (production execution, electronic work
instructions, eBR/eDHR where applicable)
Biopharma batch execution concepts (eBR/eDHR, batch genealogy/traceability,
electronic logbooks)

LIMS/ERP integration exposure (e.g., SAP, common middleware patterns) and
master-data impacts to execution

OT systems & integration skills
Requirements gathering and translation between shop-floor teams and
IT/engineering
System integration patterns (OT-to-IT data flows, historian to analytics, MES to
ERP)
Interfaces and data formats (OPC UA/DA basics, MQTT basics, REST APIs
basics; CSV/SQL data handling)

GxP compliance, CSV/CSA, and data integrity
GxP basics (GMP/GDP as applicable) and inspection readiness mindset
21 CFR Part 11 / EU Annex 11 concepts (e-signatures, audit trails, record
retention, system access controls)
Computer System Validation (CSV) / Computer Software Assurance (CSA)
participation: risk assessment, traceability, test evidence, and validation
summaries
Data integrity principles (ALCOA+) applied to electronic records and interfaces
(time sync, audit trail review, secure data transfer)
Change control and deviation support: impact assessment language, objective
evidence capture, and effective documentation

Project execution skills (Quality Execution projects)
Project lifecycle participation (scope, schedule, RAID logs, status reporting)
User story writing / acceptance criteria; support for UAT coordination
Cutover planning and hypercare support

Data, reporting, and analysis
SQL fundamentals and basic data modeling concepts

KPI definition and reporting (quality KPIs, throughput, downtime, first-pass yield)
Basic statistical/quality tools (Pareto, trend analysis, SPC concepts)

Communication & stakeholder management
Ability to communicate with operators, maintenance, quality, engineering, and IT
Facilitation skills for workshops (process mapping, pain-point capture)
Clear technical writing (requirements, test scripts, SOP/job aids)
Training support (creating materials, delivering hands-on training)