Senior Quality Validation Engineer

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

We are seeking an experienced Quality Validation Engineer to support process validation efforts within a regulated pharmaceutical manufacturing environment. This individual will provide Quality Assurance oversight throughout the entire process validation lifecycle, from initial process development through qualification and ongoing performance monitoring. The position requires a strong combination of QA expertise and hands‑on process validation experience, particularly within sterile injectable manufacturing. The selected individual will work closely with manufacturing, engineering, and technical teams to ensure validation activities meet regulatory standards while supporting process improvements, product quality, and operational compliance.

Key Responsibilities

• Provide Quality Assurance support and technical oversight for all phases of process validation, including Stage 1 (Process Design), Stage 2 (Process Performance Qualification), and Stage 3 (Continued Process Verification).
• Lead and support the preparation, execution, review, and approval of validation protocols and associated documentation for aseptically manufactured pharmaceutical products.
• Evaluate validation deliverables such as risk assessments, manufacturing process maps, qualification studies, technical reports, and process validation documentation.
• Work with cross-functional teams to establish and assess critical process parameters (CPPs) and critical quality attributes (CQAs) to ensure consistent manufacturing performance.
• Support the planning and execution of Process Performance Qualification (PPQ) activities and the development of Continued Process Verification (CPV) programs.
• Ensure validation activities align with applicable FDA and EMA regulations, ICH guidelines, internal quality standards, and established industry practices.
• Assess manufacturing process changes to determine potential validation impacts and identify appropriate qualification or revalidation requirements.
• Contribute to the creation and improvement of validation procedures, quality systems documentation, and site‑specific operating standards.
• Provide technical expertise during quality audits, customer assessments, and regulatory inspections involving process validation.
• Investigate process‑related deviations and participate in corrective and preventive action (CAPA) activities, including the evaluation and approval of associated quality records.
• Review process performance data and support statistical trending to identify opportunities for improved process control and manufacturing consistency.
• Stay informed on evolving regulatory expectations and industry guidance related to pharmaceutical process validation.

Required Qualifications

• Bachelor's degree in Engineering, Chemistry, Biology, Pharmaceutical Sciences, or another related scientific or technical discipline.
• At least 5 years of relevant experience within pharmaceutical, biotechnology, or contract manufacturing operations, with demonstrated involvement in process validation.
• Practical experience developing and executing process validation studies, including PPQ protocols, for sterile or aseptically filled pharmaceutical products.
• Strong understanding of the FDA's three‑stage process validation approach, covering process design, qualification, and continued verification.
• Experience identifying and evaluating CPPs and CQAs, interpreting manufacturing process data, and performing statistical assessments of process performance.
• Knowledge of process capability analysis, process operating ranges (NOR/PAR), and quality‑by‑design principles associated with ICH Q8.
• Familiarity with FDA and EMA expectations, EU Annex 15, ICH Q8–Q12, and applicable PDA and ISPE guidance related to validation and technology transfer.
• Experience supporting validation documentation, deviation investigations, change control assessments, and GMP quality systems.
• Understanding of process validation requirements associated with new product introductions and manufacturing technology transfers.

Preferred Experience

• Previous experience supporting sterile injectable manufacturing, aseptic filling operations, or pharmaceutical contract development and manufacturing (CDMO).
• Exposure to aseptic process simulations (media fills), product hold‑time assessments, transportation or shipping qualification, and container closure integrity testing.
• Experience participating in regulatory inspections or customer audits involving agencies such as the FDA, EMA, or Health Canada.
• Familiarity with statistical analysis software such as Minitab or JMP for process monitoring, control chart development, and capability assessments.
• Experience contributing to Annual Product Quality Reviews (APQRs), Product Quality Reviews (PQRs), or ongoing process verification activities.