What are the responsibilities and job description for the Validation Engineer position at KKR Consulting?
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.
Industry Focus:
Pharmaceutical, Biotechnology, Medical Devices
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.).
