Validation Engineer - cGMP, Process Improvement & Projects

MSD Malaysia; Ireland; Hybrid; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Hybrid working model

Job summary

MSD Malaysia is seeking an Engineering Specialist (Validation) to support Cleaning Validation & Recovery teams in a cGMP environment. The role is based at the Carlow site with a new hybrid working model.

You will design, execute and review qualification/validation documentation, lead change controls, perform root cause analysis, and drive continuous improvement while collaborating with Production, Maintenance and Quality teams.

Qualifications

• Technical qualification in applied pharmaceutical/engineering fields with proven delivery of validation/execution.
• Experience validating Tank CIP & Parts Washers and cleaning recovery studies.
• Excellent documentation, change control and deviation management skills.

Responsibilities

• Design, author, review, and execute qualification/validation documents and cycle development.
• Develop and execute change controls and investigations with robust RCA.
• Collaborate with Production, Maintenance and Quality during Cycle Development & PQ activities.
• Support regulatory audits/submissions and ensure cGMP compliance daily.
• Drive continuous improvement using Lean Six Sigma methodologies.
• Represent validation in cross-functional projects and global technical forums.

Skills

Validation experience

cGMP knowledge

Lean Six Sigma

DeltaV automation

Root cause analysis

Education

Biopharmaceutical / chemical sciences degree

Engineering qualification

Tools

DeltaV

PI System

Job description

MSD Malaysia is seeking an Engineering Specialist (Validation) to support Cleaning Validation & Recovery teams in a cGMP environment. The role is based at the Carlow site with a new hybrid working model.

You will design, execute and review qualification/validation documentation, lead change controls, perform root cause analysis, and drive continuous improvement while collaborating with Production, Maintenance and Quality teams.