Validation Engineer

PE Global; Carlow; On-site; EUR 83,000 - 124,000; Full time

Job summary

PE Global is seeking a Validation Engineer for a leading pharma client based in Carlow. This contract role focuses on supporting Sterilisation processes, autoclaves and SIP of vessels within a cGMP regulatory framework.

The successful candidate will design, execute and review qualification/validation activities, drive change controls and investigations, and collaborate with Operations, Maintenance and Quality to ensure compliant, robust processes in a fast-paced GMP environment.

Qualifications

• Relevant technical qualification in pharmaceutical/biological/chemical sciences or engineering.
• Knowledge of CTU equipment qualification and thermal mapping.
• Experience leading technical projects in GMP environments.
• Familiarity with DeltaV, Pi System and data monitoring in GMP.

Responsibilities

• Design, author, review and execute qualification/validation documentation and cycle development.
• Execute change controls and investigate deviations.
• Resolve technical issues during studies and executions.
• Engage with Production, Maintenance and Quality during cycle development and PV activities.
• Contribute to quality investigations with technical input.
• Perform root cause analysis of system failures and disturbances.
• Support Lean Six Sigma initiatives and continuous improvement.
• Represent validation on cross-functional projects and at global technical forums.
• Ensure compliance with GMP policies, procedures and guidelines.
• Support regulatory audits and submissions as required.
• Promote a safe, compliant culture in Carlow.

Skills

Validation engineering

Process monitoring

DeltaV automation

PI System

Change control

Lean Six Sigma

cGMP compliance

Thermal mapping

Root cause analysis

Sterile validation

Education

Applied Pharmaceutical/ Biological/ Chemical sciences or Engineering

Tools

CTU qualification

Thermal mapping equipment

Job description

PE Global is currently recruiting for a Validation Engineer for a leading multi-national Pharma client based in Carlow.

This is a contract position.

Role:

My client is excited to offer a fantastic Engineering Specialist (Validation) opportunity for candidates interested in a new challenge in a cGMP regulatory environment. The successful candidates will support several aspects of Validation. The roles available that will require experienced, energetic and committed engineers in Sterilisation – Autoclaves, SIP of vessels.

Responsibilities:

• Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development studies in line with the standard approval process.
• Design/Author/Review/Approve/Execute Execution/development of change controls.
• Resolving technical issues encountered during study execution.
• Engagement with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.
• Technical input into quality notification by authoring/reviewing/approving investigations.
• Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
• Support continuous improvement through Lean Six Sigma methodologies.
• Serve as validation representative for cross functional projects and represent the validation team at global technical forums.
• Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
• Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections and proactively highlighting any issues around compliance.
• Supporting regulatory audits and submissions as required.
• Work collaboratively to drive a safe and compliant culture in Carlow.

Requirements:

• Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.
• Knowledge of CTU equipment qualification.
• Knowledge of thermal mapping equipment.
• Thermal mapping skills.
• Exception / Deviation Management and Change Control.
• Demonstratable experience of leading technical related projects.
• Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable.
• Evidence of continuous professional development is desirable.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Ability to analyse and interpret complex data, and link to equipment performance and out of specification findings as appropriate.
• Report, standards, policy writing skills required.
• Equipment and process validation.
• Sterile Fill-Finish processes and equipment.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***