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.
