Validation Engineers work behind the scenes to ensure that automated equipment meets strict industry standards.
Job Summary
We are seeking a highly skilled Validation Engineer to develop and deliver validation packages for bespoke automated equipment. This role focuses on supporting FDA-regulated manufacturing customers by ensuring compliance with validation standards throughout all project stages, from proposal to final delivery.
The ideal candidate will have in-depth knowledge of GAMP requirements and a strong understanding of the software system development lifecycle for automated equipment. They will define validation strategies, plan project documentation, and execute validation activities in alignment with project objectives while optimizing cost efficiency.
This position requires excellent communication and stakeholder management skills, as well as strong organizational skills with a proactive and solutions-focused mindset. The ability to multitask and manage multiple projects effectively is also essential.
Main Responsibilities:
* Develop, review, and approve Validation Project Plans (VPP)
* Develop and review User Requirements Specifications (URS), Functional Design Specifications (FDS), Hardware Design Specifications (HDS), and Software Design Specifications (SDS)
* Create, review, and approve commissioning documentation
* Develop, review, and approve Requirements Traceability Matrix (RTM) documentation
* Assess and approve Failure Mode and Effects Analysis (FMEA) documentation
* Develop and review User Manuals
* Oversee Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) documentation
* Collect qualification test data and provide technical input to resolve discrepancies and deviations
Requirements and Qualifications:
* Bachelor's degree in Science, Engineering, or a related discipline
* Minimum of 3 years' experience in a validation role within a regulated environment
Key Skills and Abilities:
* Proven experience in developing validation documentation for the pharmaceutical and medical device industries
* Strong technical proficiency, including Microsoft Word, Excel, PowerPoint, and MS Project
* Detail-oriented with strong documentation and analytical skills
* Ability to work collaboratively across departments
About Us:
We offer a comprehensive benefits package to support our employees' well-being and professional development, including flexible work arrangements, health insurance contributions, company bonus, maternity and paternity leave, pension plan, training support, and various wellness initiatives.