What are the responsibilities and job description for the Senior Validation Engineer position at Intellectt Inc?
Job Title: Senior Validation Engineer
Location: Lebanon, IN (100% Onsite)
Duration: Long Term Contract
Position Summary
We are seeking a highly skilled Senior Validation Engineer with 3 years of experience to support a long-term equipment validation project. The role involves validation of utilities, HVAC systems, synthesis, purification, and other related equipment to ensure compliance with regulatory requirements and industry standards.
Key Responsibilities
- Plan, develop, and execute validation protocols (IQ, OQ, PQ) for utilities, HVAC, synthesis, and purification equipment.
- Ensure compliance with FDA, cGMP, and industry standards for equipment qualification and validation.
- Develop and review validation documentation including protocols, reports, and risk assessments.
- Collaborate with cross-functional teams (Engineering, Quality, Manufacturing) to support project timelines and deliverables.
- Investigate, document, and resolve validation deviations, ensuring timely closure and CAPA compliance.
- Maintain validation traceability and ensure audit readiness for regulatory inspections.
- Support change control activities impacting validated systems and equipment.
- Provide technical expertise to ensure equipment is qualified for intended use.
Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or related field.
- 3 years of experience in equipment validation within the pharmaceutical, biotech, or medical device industry.
- Hands-on experience with validation of utilities, HVAC systems, and manufacturing/purification equipment.
- Strong knowledge of FDA regulations, cGMP, and industry standards (e.g., ISPE, ICH).
- Proficiency in writing and reviewing IQ/OQ/PQ protocols and reports.
Validation Engineer
PACIV -
Indianapolis, IN
