CQV Validation Engineer

Job Title: CQV (Commissioning, Qualification, and Validation) Engineer

Location: North Carolina, United States

Job Description:

We are seeking a highly motivated CQV Validation Engineer to join our team. The ideal candidate will be responsible for ensuring that systems, equipment, and processes meet all necessary validation standards.

Core Skills:

• Strong knowledge of validation methodologies and processes
• Proficiency in developing and executing validation protocols
• Excellent problem-solving and analytical skills
• Attention to detail and strong organizational abilities
• Effective communication and teamwork skills

Responsibilities:

• Develop and execute validation protocols for commissioning, qualification, and validation of equipment and processes.
• Collaborate with cross-functional teams to ensure compliance with industry regulations and company policies.
• Perform risk assessments and gap analyses for validation projects.
• Maintain validation documentation and ensure it is up to date.
• Participate in investigations and root cause analyses related to validation failures.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 2+ years of experience in CQV validation in the pharmaceutical or biotechnology industry.
• Strong understanding of regulatory requirements (FDA, EMA, etc.).

Seniority Level: Mid-Senior level

Employment Type: Contract

Job Function: Validation Engineer

Industries: Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Biotechnology Research