Validation Engineering Specialist, cGMP

MSD; Carlow; Hybrid; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Hybrid working

Job summary

MSD, located in Carlow, Ireland, seeks an Engineering Specialist (Validation) to support Cleaning Validation & Cleaning Recovery teams in a cGMP environment. The role involves authoring, reviewing, and executing qualification activities, change controls, and investigations, with strong emphasis on compliance and quality.

You will collaborate with Production, Maintenance and Quality teams, lead validation projects, and contribute to continuous improvement using Lean Six Sigma methodologies.

Qualifications

• Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
• Experience in validation of Tank CIP & Parts Washers for in-process components.
• Experience in cleaning recovery studies using TOC and swab methods.
• Knowledge of process monitoring systems, automation systems (DeltaV), and data systems (Pi System) within a GMP environment.
• Excellent communication and teamwork skills.

Responsibilities

• Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development studies.
• Design/Author/Review/Approve/Execute execution/development of change controls.
• Perform root cause analysis of system failures and drive continuous improvement using Lean Six Sigma.
• Support regulatory audits and contribute to global quality forums.

Job description

MSD, located in Carlow, Ireland, seeks an Engineering Specialist (Validation) to support Cleaning Validation & Cleaning Recovery teams in a cGMP environment. The role involves authoring, reviewing, and executing qualification activities, change controls, and investigations, with strong emphasis on compliance and quality.

You will collaborate with Production, Maintenance and Quality teams, lead validation projects, and contribute to continuous improvement using Lean Six Sigma methodologies.