We are seeking a highly capable
Project Engineer with a strong MES focus
, specializing in
Werum PAS-X
, to support the delivery of digital manufacturing and operational excellence initiatives for a pharmaceutical client.
This role will play a key part in the implementation, enhancement, and lifecycle management of
Manufacturing Execution Systems (MES)
across GMP-regulated production environments.
The successful candidate will bring proven experience in
PAS-X design, recipe modeling, electronic batch record (EBR) deployment, system integration, and project execution
, working closely with manufacturing, automation, validation, IT, and quality teams.
Key Responsibilities
Lead or support the delivery of
MES projects with a primary focus on Werum PAS-X
.
Translate process and manufacturing requirements into:
MES functional specifications
Master batch records
Electronic workflows
Materials and equipment models
Exception handling logic
Configure and support
PAS-X modules
including:
Electronic Batch Recording (EBR)
MBR design
Weigh & Dispense
Materials Management
Review by Exception
Collaborate with process SMEs, operations, QA, and IT to optimize digital batch execution.
Manage project activities including:
Scope definition
Schedule tracking
Vendor coordination
Risk management
Change control
Stakeholder reporting
Support system integration with:
DeltaV / DCS
PLCs
LIMS
ERP / SAP
Historians
Serialization systems
Coordinate FAT, SAT, UAT, and go-live readiness activities.
Support
CSV, IQ/OQ, and validation documentation
in line with GAMP 5.
Troubleshoot MES issues during deployment, hyper-care, and steady-state operations.
Drive continuous improvement initiatives to improve batch release time, right-first-time performance, and data integrity.
Required Qualifications
Bachelor's degree in
Engineering, Computer Science, Biotechnology, Pharmaceutical Technology, or related discipline
.
5+ years of project engineering or MES delivery experience
within pharmaceutical, biotech, or life sciences manufacturing.
Strong hands-on experience with
Werum PAS-X / Körber PAS-X
.
Electronic Batch Records
Recipe / workflow design
GMP manufacturing processes
Exception management
Experience managing project timelines, deliverables, and cross-functional stakeholders.
Strong knowledge of:
GAMP 5
21 CFR Part 11
Annex 11
Data integrity principles
Excellent documentation, communication, and problem-solving skills.
Preferred Experience
Experience in
biologics, sterile fill-finish, vaccine, or API manufacturing
.
Exposure to
PAS-X rollouts, site expansions, or global template deployments
.
Familiarity with
DeltaV, Syncade, SAP, PI Historian, LIMS, and SCADA integrations
.
Experience with recipe standardization and multi-site MES harmonization.
Knowledge of ISA-88 / ISA-95 concepts.
Previous capital project or digital transformation program experience.
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