Senior Validation Engineer. - Katalyst Healthcares & Life Sciences
South Plainfield, NJ 07080
About the Job
Responsibilities:
- We are seeking a skilled Validation Engineer with experience in GxP compliance and expertise in 21 CFR Part regulations.
- The ideal candidate will have a strong background in life sciences and experience in qualifying analytical solutions.
- This role requires a detail-oriented professional who can ensure that our processes and systems meet regulatory standards.
- Ensure compliance with GxP (Good Practice) guidelines and 21 CFR Part regulations.
- Perform validation activities for analytical solutions, ensuring they meet industry standards and regulatory requirements.
- Collaborate with cross-functional teams to support the qualification and validation of equipment, processes, and systems.
- Document validation processes, including protocols, reports, and other necessary documentation.
- Provide technical expertise and guidance on compliance issues related to 21 CFR Part levels.
- Participate in audits and inspections to ensure compliance with regulatory standards.
- Proven experience as a Validation Engineer in the life sciences industry.
- Strong understanding of GxP compliance and 21 CFR Part regulations.
- Experience in qualifying and validating analytical solutions.
- Ability to work effectively within US or near US time zones.
- Excellent documentation and communication skills.
- Detail-oriented with strong problem-solving abilities.
- Prior experience working with regulatory bodies or in an FDA-regulated environment.
- Familiarity with current industry standards and best practices for validation.
Source : Katalyst Healthcares & Life Sciences
