Validation Engineer

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