CQV Validation Engineer

United Pharma Technologies Inc; North Carolina; On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is looking for a motivated CQV Validation Engineer to ensure systems and processes meet validation standards. This role involves developing and executing protocols, collaborating with cross-functional teams, and maintaining compliance with industry regulations. As part of a dynamic team in the pharmaceutical sector, you will play a crucial role in ensuring quality and safety in manufacturing processes. If you are detail-oriented and have a passion for validation in a fast-paced environment, this opportunity is perfect for you to make a significant impact.

Qualifications

• 2+ years of experience in CQV validation in the pharmaceutical industry.
• Strong understanding of regulatory requirements (FDA, EMA, etc.).

Responsibilities

• Develop and execute validation protocols for equipment and processes.
• Collaborate with teams to ensure compliance with regulations.
• Maintain validation documentation and participate in investigations.

Skills

Validation methodologies

Validation protocols development

Problem-solving skills

Analytical skills

Attention to detail

Organizational abilities

Communication skills

Teamwork skills

Education

Bachelor’s degree in Engineering

Bachelor’s degree in Life Sciences

Bachelor’s degree in a related field

Job description

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