Validation Engineer III prepares all protocols and reports for validation work. Coordinates all validation activities by constant communication with affected departments and personnel; oversees and reviews validation area processes and procedures. Being a Validation Engineer III may require a bachelor’s degree. Typically reports to a manager or head of a unit/department. The Validation Engineer III contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature. To be a Validation Engineer III typically requires 4 to 7 years of related experience.
Validation Engineer III Job Description Template
Our company is looking for a Validation Engineer III to join our team.
Responsibilities:
- Develop and recommend science-based solutions with a focus on continuous improvement and compliance;
- Review document changes for validation and deviation impact;
- Validation representative on validation projects leading by example on projects;
- Propose corrective actions to validation manager and appropriate departments to implement the required changes;
- Assist management with mentoring and training of colleagues on policies and procedures including the requirements for validation;
- Write protocols and technical study approaches.
Requirements:
- Possess strong knowledge of commissioning, qualification validation, practices, including applicable regulations;
- Proficiency in Microsoft Office including Word, Excel, Power Point, Project;
- Excellent technical writing, verbal communication and presentation skills. ;
- Ability to multitask with competing demands and at times shifting priorities;
- Travel and work at all LSNE site locations/facilities;
- Able to don ISO cleanroom gowning and PPE, as required by site procedures;
- Ability to lift up to 50 pounds;
- Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EMA) for validation of GMP facilities;
- Must be able to stand for long periods of time each day.