We are looking for a Senior Validation Engineer who will be supporting end-to-end validation activities within a GMP environment, ensuring all validation lifecycle documents, protocols, and reports are developed, reviewed, and approved in compliance with regulatory standards and internal procedures.
Key Responsibilities
- Develop, review and/or approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion.
- Lead project validation activities, and provide basic guidance and direction to junior project engineer as required.
- Review Turnover / Vendor Packages as part of the project deliverables to support qualification activities.
- Manage qualification execution and lead validation deviation investigation encountered in qualification.
- Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification activities.
- Able to manage cross function stakeholders, and to lead / facilitate meeting and discussion relevant to project qualification/ validation activities.
- Participate in site Validation Maintenance Program.
- Support Change Implementation on site. Any other tasks as and when assigned by Supervisor or Project Lead.
Requirements:
- Minimum of 5-7 years relevant experience in pharmaceutical manufacturing environment.
- Ability to multitask and work in a fast-paced environment with competing priorities.
- Great team player.
- Strong interpersonal and communication skills and ability to develop close working relationships and work collaboratively with internal and external contacts at all levels.
- Exhibit continuous improvement mindset and innovative thinking.
