Job Description:
The Validation and Qualification Engineer plays a pivotal role in ensuring ongoing validation and compliance of equipment, systems, and processes. This involves supporting new product introductions, equipment qualification, and site requalification programs.
Key Responsibilities:
* Design, execute, and report on Process Performance Qualifications (PPQs) and validation studies for equipment, systems, and processes.
* Ensure validation studies are managed in accordance with relevant standards and legal requirements, including Health & Safety, cGMP, construction, environmental, etc.
* Provide technical interpretation and guidance on current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation, and depyrogenation.
* Maintain validation documentation throughout the validation lifecycle.
* Participate in external regulatory inspections.
* Support Site Change Control process.
Required Skills and Qualifications:
* Ability to troubleshoot validation issues associated with projects and process development.
* Technical knowledge of pharmaceutical plants.
* Previous validation or product development experience is highly advantageous.
* Knowledge of Process Validation regulations, industry practices, and guidelines.
* Familiarity with GAMP and ISPE Baseline guides.
* Understanding of steam and dry heat validation publications, such as AAMI/ANSI, PDA, and ISO guidelines.
* Full understanding of relevant quality and compliance regulations.
* Ability to execute projects to plan.
* Good knowledge of quality management systems.
* Effective communication skills at all levels.