What are the responsibilities and job description for the Validation Engineer position at Shoolin Inc?
Job Title: Validation Engineer
Location: Indiana, USA (Onsite)
Experience Required: 3 Years
Employment Type: Contract / Full-Time
Job Summary:
We are seeking a skilled Validation Engineer with a minimum of 3 years of experience in pharmaceutical, biotechnology, or life sciences industries. The ideal candidate will be responsible for planning, executing, and documenting validation activities in compliance with regulatory standards. This role requires strong technical expertise in equipment, process, and cleaning validation within a GMP environment.
Key Responsibilities:
- Develop, review, and execute validation protocols including IQ, OQ, PQ for equipment, utilities, and processes
- Perform process validation, cleaning validation, and equipment qualification activities
- Ensure compliance with FDA, cGMP, and other regulatory requirements
- Author and review validation documentation such as protocols, reports, and SOPs
- Support deviation investigations, CAPA, and change control processes
- Collaborate with cross-functional teams including Quality Assurance, Manufacturing, and Engineering
- Participate in risk assessments and validation planning activities
- Ensure proper documentation and data integrity practices are followed
- Assist during internal and external audits and regulatory inspections
Required Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, or related field
- Minimum 3 years of validation experience in a regulated industry
- Strong knowledge of cGMP, FDA regulations, and validation lifecycle
- Hands-on experience with IQ/OQ/PQ, process validation, and cleaning validation
- Familiarity with validation documentation and compliance standards
- Excellent problem-solving and analytical skills
- Strong written and verbal communication skills
Preferred Qualifications:
- Experience with Kneat or other validation lifecycle management systems
- Exposure to utilities validation (HVAC, water systems, clean steam, etc.)
- Knowledge of data integrity and 21 CFR Part 11 compliance
- Prior experience in pharmaceutical or biotech manufacturing environments