Senior Process Validation Engineer - Sterile Pharma QA

Harba Solutions Inc.; Indianapolis (IN); On-site; USD 110,000 - 140,000; Full time

Job summary

Harba Solutions Inc. is seeking an experienced Quality Validation Engineer to lead process validation activities in a regulated pharmaceutical manufacturing environment, including sterile products.

The role provides QA oversight across stages from design through continued verification and requires collaboration with manufacturing and engineering teams. The ideal candidate has hands-on PPQ and CPV experience, familiarity with FDA/EMA expectations, and a track record of improving process

Qualifications

• Bachelor's degree in Engineering, Chemistry, Biology or related field.
• 5+ years in pharma/biotech with process validation experience.
• Experience in PPQ protocols for sterile or aseptically filled products.
• Knowledge of FDA/EMA regulatory expectations and ICH guidelines.

Responsibilities

• Provide QA support and oversight for Stage 1, Stage 2, and Stage 3 of process validation.
• Lead development, execution, review, and approval of validation protocols and documentation for aseptically manufactured products.
• Evaluate validation deliverables such as risk assessments, process maps, qualification studies and technical reports.
• Identify CPPs and CQAs and assess manufacturing data to ensure consistent performance.
• Support PPQ activities and development of CPV programs.
• Ensure validation activities comply with FDA, EMA, ICH, PDA and ISPE guidelines.
• Assess changes to manufacturing processes for validation impact and revalidation needs.
• Contribute to validation procedures and site quality systems documentation.
• Provide QA expertise during audits and regulatory inspections related to validation.
• Investigate deviations and participate in CAPA related to process validation.
• Review process performance data and support statistical trending for control improvements.
• Stay updated on evolving regulatory expectations for process validation.

Skills

Quality Assurance

Process Validation

Regulatory Compliance

Statistical Analysis

Education

Bachelor's degree in Engineering/Science

Tools

Minitab

JMP

Job description

Harba Solutions Inc. is seeking an experienced Quality Validation Engineer to lead process validation activities in a regulated pharmaceutical manufacturing environment, including sterile products.

The role provides QA oversight across stages from design through continued verification and requires collaboration with manufacturing and engineering teams. The ideal candidate has hands-on PPQ and CPV experience, familiarity with FDA/EMA expectations, and a track record of improving process