Ignition Engineer / Consultant

Ignition Engineer / Consultant Pharmaceutical Client

Job Title

Ignition Engineer / Consultant

Industry Domain

Pharmaceutical / Life Sciences (GxP-regulated Manufacturing)

Experience Required

5-10 years

Employment Type

Full-time

Location

Chennai//Kochi/Coimbatore - Hybrid

Role Overview

We are looking for an experienced Ignition Engineer/Consultant to support a pharmaceutical manufacturing client on the design, configuration, development, and validation of a plant-wide automation and MES/SCADA solution built on the Inductive Automation Ignition platform. The candidate will work closely with automation, MES, and quality/validation teams to deliver a GxP-compliant, scalable, and secure industrial application platform, from estimation and solution design through to build, testing, and qualification.

Key Responsibilities

• Design, develop, and configure applications on Ignition (Gateway, Designer, Vision/Perspective clients) for plant automation and supervisory control.
• Develop and configure Ignition Tag Historian, Ignition Perspective/Vision visualization clients, and OPC UA/DA connections and device drivers for data acquisition and visualization.
• Build scalable, template-driven UDT (User Defined Type) models and reusable Perspective/Vision templates to support multi-site or multi-line rollouts.
• Support integration between Ignition and MES/L3 systems (e.g., Ignition MES modules, Sepasoft, third-party MES, LIMS, ERP) commonly used in pharma manufacturing.
• Prepare effort and cost estimations, solution architecture documents, and technical proposals for Ignition implementation projects.
• Ensure solutions comply with GxP, 21 CFR Part 11 (electronic records/electronic signatures), and data integrity (ALCOA+) principles.
• Author and execute validation lifecycle documentation — URS, FRS/FDS, DQ, IQ, OQ, PQ, Traceability Matrix — in line with GAMP 5 methodology.
• Configure alarms, security/identity providers, redundancy (Gateway redundancy/Ignition Enterprise Administration), and disaster recovery for high-availability plant operations.
• Collaborate with automation (PLC/DCS), instrumentation, and IT/OT infrastructure teams to ensure seamless system integration.
• Conduct FAT/SAT, commissioning, and post-go-live support/troubleshooting at client site.
• Support change control, periodic review, and system revalidation activities per client quality procedures.
• Provide technical documentation, as-built drawings, and knowledge transfer/training to client operations and support teams.

Pharmaceutical / Regulatory Domain Expertise (Preferred)

• Sound knowledge of GAMP 5 computerized system validation (CSV/CSA) lifecycle and documentation practices.
• Working knowledge of 21 CFR Part 11, EU Annex 11, and data integrity (ALCOA+) requirements.

Certifications (Preferred)

• Inductive Automation Ignition certification (Gold/Silver Certified Ignition Specialist).
• GAMP 5 / CSV training certification.
• ISA-95 / ISA-88 or relevant automation standards training.

Soft Skills & Other Requirements

• Strong client-facing communication skills; ability to work directly with pharma quality, validation, and automation stakeholders.
• Ability to prepare and present technical estimations, proposals, and solution walkthroughs to client/hiring stakeholders.
• Strong documentation discipline suited to regulated/validated environments.
• Good analytical and troubleshooting skills for live plant support scenarios.