Validation Engineer

Job Title: Validation Engineer

Location: Indiana (Onsite)

Job Type: Contract

Experience Required: 4–6 Years

Industry: Pharmaceutical Manufacturing

Position Summary

We are seeking a motivated Validation Engineer with 4–6 years of pharmaceutical industry experience to support validation activities within a GMP-regulated manufacturing environment. The successful candidate will be responsible for the planning, execution, and documentation of validation projects, ensuring compliance with FDA regulations, cGMP requirements, and internal quality standards.

This role requires strong technical expertise in equipment, utility, process, and cleaning validation, along with the ability to work collaboratively across Engineering, Manufacturing, Quality Assurance, and Regulatory teams.

Key Responsibilities

• Develop, execute, and review validation protocols and reports, including:
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Support validation activities for manufacturing equipment, process systems, utilities, and facilities.
• Perform risk assessments and validation impact assessments for new equipment, process changes, and engineering projects.
• Execute commissioning and qualification activities for pharmaceutical manufacturing systems.
• Support cleaning validation studies, sampling activities, and data analysis.
• Review engineering documentation, P&IDs, specifications, and vendor documentation to ensure validation requirements are met.
• Investigate validation deviations, discrepancies, and non-conformances and assist in implementing corrective and preventive actions (CAPAs).
• Ensure validation documentation complies with FDA, cGMP, ICH, and company quality standards.
• Collaborate with Quality Assurance, Manufacturing, Facilities, and Engineering teams to support project timelines and regulatory compliance.
• Participate in audits and inspections by regulatory agencies and internal quality groups.
• Maintain validation lifecycle documentation and support continuous process improvement initiatives.

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related technical field.
• 4–6 years of validation experience within the pharmaceutical, biotechnology, or life sciences industry.
• Hands-on experience with equipment qualification and validation activities in a GMP-regulated environment.
• Strong knowledge of FDA regulations, cGMP requirements, and validation principles.
• Experience authoring and executing IQ/OQ/PQ protocols and validation reports.
• Familiarity with deviation investigations, CAPA processes, and change control systems.
• Strong technical writing and documentation skills.
• Excellent communication and cross-functional collaboration abilities.

Preferred Qualifications

• Experience with process validation, cleaning validation, or utility qualification.
• Knowledge of ASTM, ISPE, GAMP 5, and risk-based validation methodologies.
• Experience supporting sterile, oral solid dosage, biologics, or API manufacturing environments.
• Familiarity with electronic quality systems such as TrackWise, Veeva, MasterControl, or similar platforms.
• Previous involvement in commissioning and qualification (C&Q) projects.