What are the responsibilities and job description for the Senior Validation Engineer position at Guerbet?
WHAT WE'RE LOOKING FOR
We’re seeking a highly motivated and detail-oriented Sr. Validation Engineer to lead and support validation activities across equipment, utilities, and computer systems in a pharmaceutical manufacturing environment. This role is essential to ensuring compliance with cGMP, GLP, and FDA regulations while driving continuous improvement and operational excellence. You’ll collaborate with cross-functional teams, provide technical guidance, and take ownership of validation deliverables from planning through execution.
This is an on-site position located in Raleigh, NC.
YOUR ROLE
- Author, execute, and summarize validation protocols for equipment, utilities, and computer systems
- Coordinate and manage validation projects, ensuring timely and compliant execution
- Develop and revise procedures to align with cGMP, GLP, and FDA regulations
- Provide technical input on new equipment and modifications to maintain validated status
- Support investigations related to critical equipment, processes, and utilities
- Train personnel on validation procedures and compliance standards
- Recommend policy and procedural changes to enhance regulatory compliance
- Notify management of deviations and recommend corrective actions for out-of-spec systems
- Conduct special projects and provide technical support as directed by management
- Maintain a safe working environment and report safety or environmental concerns promptly
YOUR BACKGROUND
Education
- Bachelor’s degree in Engineering, Life Sciences, or equivalent validation experience
Experience
- 2–6 years of validation experience in a pharmaceutical manufacturing environment
Skills/Competencies
- Strong knowledge of cGMP, GLP, and FDA regulations
- Experience with pharmaceutical equipment, cleaning validation, and steam sterilization
- Proficiency in writing protocols, reports, and technical documentation
- Ability to apply advanced mathematical and statistical principles
- Skilled in problem-solving, data analysis, and drawing valid conclusions
- Proficient in MS Office (Word, Excel, PowerPoint, Access) and database tools
- Effective communicator with strong technical writing and interpersonal skills
- Self-motivated, organized, and capable of managing multiple priorities
- Demonstrated accountability and ability to meet deadlines with high accuracy