Job Description

Job Summary

We are seeking an experienced

Senior MES Lead / MES Solution Architect

with deep expertise in

pharmaceutical manufacturing, GxP systems, and MES recipe authoring

. The role involves

end-to-end MES implementation

, including

process design, EBR/MBR development, validation (CSV), system integration

, and

team leadership

. The candidate will work closely with clients at manufacturing sites to drive digital manufacturing transformation aligned with

ISA-88, GAMP 5, and global regulatory standards

.

Key ResponsibilitiesMES & Digital Manufacturing

Lead

discovery workshops

at client sites to understand manufacturing processes, user requirements, and business needs. Analyze

business process flows

, identify gaps, and design

operations, unit procedures, and recipes

aligned with

ISA-88 standards

and

Manufacturing Batch Records (MBR)

. Design, configure, and implement

Electronic Batch Records (EBR)

within MES platforms. Execute

end-to-end dry runs

and deploy

validated master recipes

prior to Go-Live. Ensure successful production runs by

risk assessment, troubleshooting, deviation investigation

, and MES issue resolution.

MES Platforms & Integration

Hands-on experience with MES platforms such as:

Siemens Opcenter

Werum PAS-X

Tulip

Define and support

solution architecture

including: Hardware, software, and network components Integration with

ERP, LIMS, QMS, L2 systems

Support integration of

weighing scales, barcode scanners, printers

, and shop-floor equipment. Configure customer-specific system settings and

reporting solutions (MS SSRS)

.

Validation & Compliance (CSV)

Define and manage the

Project Validation Plan (PVP)

. Prepare and maintain validation deliverables:

IQ, OQ, PQ

Risk Assessment, Impact Assessment

Traceability Matrix (RTM)

Lead

GxP assessments

, system-level and functional risk analysis. Manage protocol execution, review, and approvals in collaboration with customer validation teams. Ensure compliance with:

21 CFR Part 11

EU Annex 11

ICH Guidelines

ISPE GAMP 5

Leadership & Stakeholder Management

Manage and mentor a team of

MES / Process Engineers

. Act as a key interface between

clients, internal teams, quality, and IT stakeholders

. Participate in

internal and external audits/inspections

. Develop

reusable templates, workflows, and building blocks

to support scalable MES delivery. Effectively communicate complex technical and regulatory concepts to stakeholders and inspectors.

Required Skills & ExperienceExperience

8+ years

of experience in

pharmaceutical or biotech manufacturing environments

. Strong background in

MES, EBR, Automation, SCADA, Historian

, and validation projects. End-to-end experience across the

full project lifecycle

(design ? build ? test ? validation ? go-live). Experience leading

medium to large pharma MES programs

.
Job Type: Full-time

Pay: ?100,985.52 - ?163,474.62 per month

Work Location: Remote