What are the responsibilities and job description for the Validation Engineer position at EnIn Systems?
Key Responsibilities:
- Develop and execute validation protocols (IQ, OQ, PQ) for systems, equipment, and processes.
- Ensure compliance with FDA, ISO, GMP, GxP, and industry-specific regulations.
- Perform risk assessments and failure mode analysis (FMEA) for validation processes.
- Collaborate with engineering, manufacturing, and quality teams to develop validation strategies.
- Prepare and review validation documentation, reports, and regulatory submissions.
- Support process improvements and continuous validation activities.
- Troubleshoot validation failures and implement corrective actions.
- Stay updated with industry regulations and validation best practices.
Required Skills & Qualifications:
- Education: Bachelor's or Master’s degree in Engineering (Mechanical, Electrical, Chemical, Biomedical, or related field).
- Experience: 10 years in validation, quality assurance, or related roles in pharmaceutical, biotech, medical devices, or manufacturing industries.
- Strong knowledge of FDA 21 CFR Part 11, ISO 13485, 21 CFR Part 820, and GAMP 5.
- Hands-on experience with validation protocols, equipment qualification, and process validation.
- Proficiency in statistical analysis tools (Minitab, JMP, etc.) and risk-based validation approaches.
- Excellent documentation, communication, and problem-solving skills.
Preferred Qualifications:
- Experience in CSV (Computer System Validation) or Software Validation.
- Familiarity with automation systems, PLCs, and SCADA.
- Certification in CQE, Six Sigma, or Lean Manufacturing.
