Talent.com
This job offer is not available in your country.
Validation Engineer

Validation Engineer

Recruitment by Aphex GroupCarlow, Leinster, Republic of Ireland
15 days ago
Job description

This is an 11-month initial contract. Purpose : We are seeking a skilled Validation Engineer to support qualification activities in a cGMP regulatory environment, focusing on Isolator Airflow Visualisation, VHP, and HVAC Qualification. Responsibilities : Design, author, review, approve, and execute qualification / validation documentation and studies. Develop and manage change controls, resolving technical issues during study execution. Collaborate with cross-functional teams to ensure compliance during Cycle Development & Performance Qualification. Conduct root cause analysis for system failures and substandard performance using standard tools. Support continuous improvement through Lean Six Sigma methodologies. Represent validation in cross-functional projects and global technical forums. Ensure compliance with global policies, regulatory requirements, and cGMP standards. Participate in audits, investigations, and quality notifications. Qualifications : Experience in Isolator Airflow Visualisation / VHP / HVAC Qualification documentation. Technical qualification in Pharmaceutical / Biological / Chemical Sciences or Engineering. Proficiency in Exception / Deviation Management, Change Control, and process validation. Knowledge of GMP manufacturing, automation systems (DeltaV), and data systems (Pi System). Strong analytical, communication, and project management skills. Familiarity with sterile fill-finish processes and regulatory requirements. Advantageous Skills : Filter Validation, CCI qualification, Shipping Qualification. Equipment Periodic Validation, Autoclave / SIP Sterilisation, Cleaning Validation. Experience with vial / syringe processing technologies. Skills : HVAC Isolators VHP Validation

Create a job alert for this search

Validation Engineer • Carlow, Leinster, Republic of Ireland