06 Aug
|
NR Consulting
|
Hyderabad
06 Aug
NR Consulting
Hyderabad
Title: Project Manager - MES
Location: Hyderabad
Exp: 8+ Years
Key Responsibilities (Non-Junior / Ownership Language)
- Own end-to-end project delivery for MES implementations, upgrades, and enhancements, including execution planning through hypercare/handover.
- Define and control scope : establish project objectives, deliverables, milestones, success criteria, and acceptance conditions with stakeholders.
- Build and maintain the integrated project plan (workstreams, dependencies, critical path, resourcing), and drive adherence across teams.
- Lead cross-functional execution across Manufacturing, Quality, Validation, Engineering, Automation/OT, IT, and vendors/partners to deliver committed outcomes.
- Own RAID management (Risks, Assumptions, Issues, Dependencies): proactively identify, quantify impact, drive mitigations, and escalate with clear options/recommendations .
- Run governance and stakeholder communication : steerco/operating reviews, project meetings, decisions, minutes/actions, and executive-ready status reporting.
- Own change control for project impacts : manage scope/timeline/cost changes, ensure approvals, and maintain decision traceability.
- Plan and coordinate testing execution : UAT and system testing planning with SMEs, defect triage cadence, prioritization, and closure of critical defects.
- Drive validation readiness in partnership with QA/Validation : ensure planning and delivery align to CSV lifecycle expectations and inspection-ready documentation standards.
- Track project financials and resources : budget estimates, forecasting, variance analysis,
and capacity planning; highlight risks early and propose tradeoffs.
- Lead change management enablement : training coordination, readiness checkpoints, cutover/handover plans, and stabilization to operations/support.
- Vendor partner management (as applicable): manage timelines, deliverables, escalations, and performance against SOWs.
Required Qualifications (Project Manager, not Junior)
- Bachelors degree in Pharmacy, Life Sciences, Engineering, IT, or Business Administration (or equivalent experience).
- 8+ years experience in project management / IT delivery / manufacturing systems within pharma, biotech, medical devices, or other regulated environments .
- Demonstrated ownership of integrated schedules , RAID , governance , change control , and delivery coordination across cross-functional teams.
- Working knowledge of pharmaceutical manufacturing fundamentals and the realities of shop-floor execution (deviations, batch operations, constraints).
- Practical understanding of SDLC (waterfall and/or Agile hybrid) and core PM disciplines (scope, schedule, cost, quality, comms).
- Strong documentation discipline and ability to produce audit-ready artifacts (plans, minutes, decision logs, traceability,
status packs).
- Proficient with MS Office ; experience with MS Project / Smartsheet / Jira strongly preferred.
Preferred Qualifications
- Experience delivering or supporting MES platforms such as Rockwell PharmaSuite , Werum Client-X , Syncade , Camstar , Opcenter , etc.
- Experience with CSV concepts and deliverables (e.g., validation plans, requirements traceability, test protocols, summary reports) in GxP settings.
- Solid familiarity with GMP / GxP , data integrity , and 21 CFR Part 11 expectations (awareness level is acceptable; deep SME not required).
- Exposure to IT/OT interfaces , shop-floor connectivity, and manufacturing digital systems (e.g., LIMS, SCADA, historians, ERP integrations).
Key Skills
- Project Planning Scheduling (critical path, dependencies, resource loading)
- RAID Management Escalation
- Stakeholder Management Executive Communication
- Governance Status Reporting (SteerCo packs, decision logs)
- Change Control / Scope Timeline Management
- Budget Forecast Tracking (variance explanations)
- Cross-functional Execution (Manufacturing / QA / Validation / IT / Engineering)
- Regulatory Awareness (GxP/GMP/CSV; Part 11 awareness)
- Testing Coordination (UAT, defect triage, readiness)
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Disclaimer : This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
📌 Project Manager - MES (Hyderabad)
🏢 NR Consulting
📍 Hyderabad