Hybrid GMP Validation Engineer – Specialist

MSD Ireland; Carlow; Hybrid; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Hybrid working model

Flexible working arrangements

Job summary

MSD Ireland, Carlow site, is seeking an Engineering Specialist (Validation) to support Cleaning Validation & Cleaning Recovery Teams in a cGMP environment. The role involves designing, authoring and executing qualification and validation studies, as well as change controls and investigations.

You will engage with Production, Maintenance and Quality, perform root cause analyses, and drive improvements using Lean Six Sigma methodologies within a global framework.

Qualifications

• Qualification in a relevant technical field with track record of delivery in validation.
• Experience in Tank CIP and Parts Washers validation for in-process components.
• Knowledge of regulatory requirements in GMP environments.
• Strong report writing and investigation capabilities.

Responsibilities

• Design/validate/execute qualification and validation documentation.
• Develop change controls and manage deviations and investigations.
• Lead technical projects and liaise with Production, Maintenance and Quality.
• Perform root cause analysis and support continuous improvement using Lean Six Sigma.
• Provide validation input for cross-functional projects and audits.

Skills

Biopharmaceutical Operations

Change Control Processes

Deviation Management

Standards Compliance

Sterile Processing

Technical Project Management

Technology Transfer

Education

Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification

Tools

DeltaV

PI System

TOC & Swab Methods

Microsoft Office

Job description

MSD Ireland, Carlow site, is seeking an Engineering Specialist (Validation) to support Cleaning Validation & Cleaning Recovery Teams in a cGMP environment. The role involves designing, authoring and executing qualification and validation studies, as well as change controls and investigations.

You will engage with Production, Maintenance and Quality, perform root cause analyses, and drive improvements using Lean Six Sigma methodologies within a global framework.