Functional Lead

Opcenter Execution Pharma – Techno-Functional

Job Title

Opcenter Execution Pharma – Techno-Functional

Designation : Associate, Senior Associate and Manager

Experience : 4 to 12 years

Salary : 10+Lacs to 25+Lacs

Location : PAN India

Job Summary

Be part of a high-impact global digital transformation program in the pharmaceutical sector.

As the Techno-Functional Lead for Opcenter Execution Pharma, you will play a pivotal role in designing, configuring, and rolling out next-generation electronic Batch

Recording (eBR / MBR) solutions across multiple manufacturing sites worldwide.

This is a true leadership position combining deep functional expertise with hands-on configuration and team leadership.

You will bridge the gap between pharmaceutical manufacturing operations and cutting-edge MES technology, delivering compliant, efficient, and harmonized global Master Batch Records that directly contribute to patient safety and operational excellence.

Key Responsibilities

Time Responsibility. Engage with business SMEs, key users, and site leadership to deeply understand current and future manufacturing processes (upstream, downstream, fill-finish, oral solid dosage, etc.)

Lead the design and configuration of Production Instructions (PIs), workflows, and Master Batch Records (MBRs) tailored to site-specific needs

Identify common processes across sites and design reusable Global PIs /

Global MBR templates for maximum harmonization and faster rollouts

Drive validation activities including review and approval of PIs, risk assessments, and traceability matrices

Author and review GAMP 5-compliant documentation (URS, FRS, Configuration Specifications, Test Scripts, Deviation Reports, etc.)

Lead and mentor a team of MES functional consultants and configurators; assign tasks, track progress, and ensure quality delivery

Ongoing Report status, risks, and achievements to leadership and customer program management

Essential Skills & Experience

Extensive hands-on experience in Opcenter Execution Pharma / Simatic IT eBR (design, configuration, and validation of MBRs / PIs)

Strong functional knowledge of pharmaceutical manufacturing processes (GMP environment)

Strong experience in creating and reviewing GxP documentation (URS, FRS, DS, IQ / OQ / PQ protocols, traceability matrices)

Prior experience leading or mentoring a team of functional / configurators

Solid understanding of ISA-88, ISA-95, and GAMP 5 principles

Nice-to-Have Skills

Experience with Opcenter Execution Core (Discrete / Process) or other MES platforms (PAS-X, Rockwell PharmaSuite, POMSnet)

Knowledge of Review-by-Exception (RbE), dynamic scheduling, or integration with ERP (SAP) and LIMS

Certification in Opcenter / MES solutions

Experience in large-scale global rollout programs

Location & Work Model

Hybrid / Remote with occasional travel to client sites (Europe, US, or Asia based on project phase)

Please Mail me your updated profile to victorpaul@livecjobs.com

With Regards,

Victor