**Validation Engineer Role Summary
This position involves providing technical support to the validation team, ensuring that all equipment and processes meet regulatory requirements.
The ideal candidate will have a strong understanding of GMP regulations and experience in a similar role within a pharmaceutical manufacturing setting.
Responsibilities include designing, authoring, reviewing, approving, and executing qualification/validation documentation and studies, managing change controls, resolving technical issues, and collaborating with production, maintenance, and quality teams.
A relevant technical qualification in applied pharmaceutical, biological, or chemical sciences or engineering is required, as well as proven experience in a comparable validation role.
Candidates should also possess strong knowledge in one or more of the following areas: CTU qualification, thermal mapping, sterilization, cleaning, isolator systems, filter validation, or container closure integrity.
Exception deviation management and change control experience, as well as leadership skills, are highly valued in this role.
Able candidates should be familiar with automation systems, data systems, regulatory requirements, and sterile fill-finish processes.
Key Responsibilities:
* Design and author qualification/validation documentation and studies
* Manage change controls and resolve technical issues
* Collaborate with production, maintenance, and quality teams
* Leverage Lean Six Sigma methodologies for continuous improvement
Required Skills and Qualifications:
* Relevant technical qualification in applied pharmaceutical, biological, or chemical sciences or engineering
* Proven experience in a comparable validation role within a GMP manufacturing setting
* Strong knowledge in one or more of the following areas: CTU qualification, thermal mapping, sterilization, cleaning, isolator systems, filter validation, or container closure integrity
* Experience with exception/deviation management and change control
* Demonstrable experience leading technical projects