Overview
Validation Analyst Jobs in United States at Invent Staffing
Title: Validation Analyst
Company: Invent Staffing
Location: United States
Key Responsibilities:
· Develop and review validation documentation with the site CSV team to ensure compliance with internal procedures and regulatory standards.
· Identify and implement opportunities to streamline CSV activities while maintaining full compliance.
· Coordinate and monitor various validation phases, providing regular project updates and ensuring timely execution.
· Create and execute validation test scripts to confirm that systems meet cGMP and regulatory requirements.
· Support audits by providing documentation and ensuring compliance during internal and regulatory inspections.
· Lead change control processes and investigate issues related to validated systems.
· Offer guidance on system upgrades and update operating procedures as needed.
· Review CSV procedures and participate in meetings to maintain high documentation quality.
Qualifications:
· Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field.
· Proven experience in CSV and regulatory compliance within a highly regulated industry (e.g., pharmaceutical, healthcare).
· Hands-on experience with environmental monitoring equipment, such as particle counters.
· Strong understanding of cGMP, FDA, and other regulatory standards.
· Proficiency in generating validation documentation (protocols, qualification reports) and managing change control activities.
· Ability to manage multiple projects in a fast-paced environment with strong problem-solving skills and a drive for continuous process improvement.
· Excellent communication and interpersonal skills, with experience supporting audit activities.
