Posted:2 weeks ago|
Platform:
Work from Office
Full Time
Manager, MES & L2 project coordinator
G10
Global IT
Manufacturing IT
Halol/Baska
0
We are seeking a seasoned professional with 7-9 years of experience in the pharmaceutical industry, including hands-on expertise in Manufacturing Execution Systems (MES) and L2 integration.
Responsibilities include stakeholder management, managing project timelines, risks, and dependencies, ensuring infrastructure readiness, facilitating change management, and maintaining compliance with site validation and quality standards. As the single point of contact for MES implementation at the site, the site coordinator plays a critical role in driving collaboration and successful deployment. The ideal candidate will ensure adherence to global regulations (FDA 21 CFR Part 11, EU GMP, GAMP5)
Project Coordination:
Lead and coordinate all MES implementation activities at the site, ensuring alignment with the global MES strategy.
Stakeholder Management:
Serve as the single point of contact for site-level stakeholders, including QA, QA IT, IT, SAP, and business users (Production & Engineering)
Vendor & Partner Collaboration:
Work closely with MES vendors, infrastructure teams, and integration partners to ensure smooth execution.
Timeline & Risk Management:
Manage project schedules, track milestones, identify risks, and implement mitigation plans.
Infrastructure & Readiness:
Ensure site infrastructure (network, servers, systems) is ready and validated for MES deployment.
Compliance & Validation:
Oversee adherence to site quality standards, IT validation (CSV), and regulatory requirements.
Communication & Reporting:
Maintain clear and timely communication with the Global Project Manager and other stakeholders; provide regular updates and escalate issues as needed.
Change Management:
Facilitate change control processes and support user readiness and adoption.
Less
Global Project Manager - MES Program
Site QA and QA IT teams
Site IT and Infrastructure teams
Production, Operations teams
SAP Coordinators
Site SME and Global SME
MES vendors and implementation partners
System integrators (L2/PLC/SCADA)
Infrastructure service providers (network/server)
Validation consultants (if outsourced)
Auditors (during validation or compliance reviews)
Halol/Baska site
No direct financial authority
Bachelor s degree in Engineering, Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field.
Preferred: Master s degree (e. g. , MBA, M. Tech, M. Pharm) with specialization in Project Management, Operations Management, Industrial Automation, or Pharmaceutical Technology.
PMP - for structured project execution (Preferred)
GAMP5 or CSV Training - for compliance in regulated environments
7-9 years of experience managing IT or digital transformation projects, preferably in pharmaceutical manufacturing.
Hands-on experience with MES platforms, L2/PLC systems, and SAP integration and Edge Cloud IoT.
Proven track record in project planning, stakeholder coordination, and cross-functional team leadership.
Strong background in GxP compliance, CSV, and validation protocols (IQ/OQ/PQ).
Experience working on the shop floor and with QA, IT, and business teams in a regulated environment.
Knowledge of data analytics tools
Edge Cloud deployment experience with (IoT and and IIoT)
L2 integration with MES
MES integration with SAP
Understanding of network and databases
sun pharma industries
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