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, hypercare, 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.
Proven expertise in:
Electronic Batch Records
Recipe / workflow design
GMP manufacturing processes
Master data modeling
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.
Key Competencies
MES project delivery
Werum PAS‑X expertise
EBR optimization
Stakeholder management
GMP compliance mindset
Cross‑functional collaboration
Risk and issue management
Continuous improvement
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