Role Summary
The Manufacturing Operations Analyst serves as the critical bridge between aseptic manufacturing operations and IT/analytics teams. This role is responsible for interpreting and correlating Vision AI insights with multiple manufacturing systems to generate actionable, GMP‑aligned intelligence for sterile and aseptic production environments.

The analyst ensures that cross‑system data is interpreted with strong manufacturing context—reducing false positives, strengthening QA confidence, and enabling faster, audit‑ready decision‑making.

Key Responsibilities
1️⃣ Operational Interpretation of Vision AI Signals

Operator interventions

Glove usage patterns

Vial movement and stability

Line stoppages and micro‑events

Interpret signals within operational context:

Batch phase (startup, steady‑state, shutdown)

Shift changes and handovers

Aseptic practices and SOP‑driven behaviors

Correlate Vision AI events with:

MES / eBR systems

SCADA alarms and event logs

Batch records and timestamps

Equipment and environmental monitoring data

Identify:

Leading indicators visible only through vision systems

Lagging indicators captured by digital systems

Gaps where traditional systems miss real‑world behavior

Perform batch‑wise and shift‑wise analytics

Support Root Cause Analysis (RCA) and CAPA development

Reduce false positives and misinterpretation of AI signals





Provide contextual and visual evidence for:

Deviation reports

CAPAs

4️⃣ QA- and Audit‑Ready Insight Generation

Explicit operational narratives

QA‑friendly summaries

Audit‑ready documentation

GMP‑aligned explanations suitable for regulatory review

5️⃣ Collaboration with IT, Data & Engineering Teams

Define operationally meaningful signals

Ensure correct temporal alignment of data

Provide process‑aware requirements for dashboards and models

Enable scalable analytics grounded in manufacturing reality

Track and report on KPIs including:

Deviation prevention

Sterility risk reduction

Operational efficiency improvements

Present findings in executive‑ and operations‑ready formats.

Required Experience
10+ years of experience in pharmaceutical manufacturing operations , specifically in:

Aseptic fill‑finish

Cleanroom manufacturing environments

10+ years in pharma manufacturing operations (aseptic / sterile)

Strong GMP knowledge and deviation management experience

Hands‑on experience with batch manufacturing & shift operations

Direct involvement in RCA and CAPA processes

Experience with MES / eBR and SCADA systems

Ability to translate operational data into QA- and audit‑ready narratives

Working knowledge of Python

Experience with visualization tools (Power BI or similar)

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📌 Manufacturing Operations Specialist (Manitoba)
🏢 NLB Services
📍 Manitoba