Our Work MattersAt Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will MakeThe Process Validation Engineer is a member of the Manufacturing Science & Technology (MS&T) organization responsible for supporting the development, execution, and lifecycle management of process validation activities for pharmaceutical and sterile injectable products. The role focuses on Process Performance Qualification (PPQ), Continued Process Verification (CPV), technology transfer support, process monitoring, and validation documentation. The engineer collaborates with Manufacturing, Quality, Process Development, Engineering, and Regulatory Affairs to ensure manufacturing processes are robust, compliant, and capable of consistently producing high-quality products.
Role Responsibilities: Process Validation & PPQ- Author and execute Process Performance Qualification (PPQ) protocols, reports, sampling plans, and validation documentation.
- Support development and implementation of process validation strategies in accordance with FDA, EMA, and ICH guidelines.
- Coordinate validation activities with Manufacturing, Quality Control, Quality Assurance, and Engineering teams.
- Analyze validation data and perform statistical evaluations to assess process capability and performance.
- Support process risk assessments using tools such as FMEA and process mapping.
- Ensure validation activities are completed in compliance with cGMP requirements and site procedures.
Continued Process Verification (CPV)- Monitor and trend critical process parameters (CPPs) and critical quality attributes (CQAs).
- Generate CPV reports and evaluate process performance data to identify trends and opportunities for improvement.
- Support investigations related to process deviations, out-of-trend results, and process excursions.
- Participate in implementation and verification of corrective and preventive actions (CAPAs).
Technology Transfer Support- Support technology transfer activities for new products, process improvements, and manufacturing scale-up projects.
- Assist in developing process descriptions, manufacturing instructions, and transfer documentation.
- Participate in process fit-gap assessments and risk evaluations.
- Support equipment qualification, facility readiness assessments, and process characterization activities.
Process Monitoring & Continuous Improvement- Utilize statistical tools and process data to identify process variability and opportunities for optimization.
- Support process robustness initiatives and operational excellence projects.
- Assist in development of process control strategies and process capability assessments.
- Participate in root cause investigations and implementation of process improvements.
Documentation & Compliance- Prepare, review, and maintain validation protocols, reports, technical assessments, and supporting documentation.
- Ensure documentation is accurate, complete, and inspection-ready.
- Support change control assessments and validation impact evaluations.
- Participate in internal audits, customer audits, and regulatory inspections as a subject matter expert for assigned validation activities.
Cross-Functional Collaboration- Work closely with Manufacturing, Quality, Process Development, Regulatory Affairs, and Engineering teams.
- Provide technical support for manufacturing operations and process troubleshooting.
- Assist with regulatory submissions and responses related to process validation and manufacturing process performance.
- Present validation findings and recommendations to cross-functional teams and site leadership.
Basic Qualifications- Bachelor's degree in Engineering, Pharmaceutical Sciences, Biotechnology, Life Sciences, or related technical field.
- 5+ years of experience in pharmaceutical, biopharmaceutical, or sterile injectable manufacturing.
- Experience with process validation, PPQ execution, CPV, technology transfer, or manufacturing support activities.
- Working knowledge of cGMP regulations, FDA guidance, and ICH validation principles.
- Strong technical writing, analytical, and problem-solving skills.
- Experience with statistical analysis tools such as JMP, Minitab, or equivalent software.
Preferred Qualifications: - Experience in sterile injectable, aseptic manufacturing, biologics, or combination products.
- Familiarity with visual inspection, assembly, labeling, serialization, and packaging operations preferred.
- Knowledge of process characterization, process capability analysis, and statistical process control.
- Experience supporting technology transfer activities.
- Experience supporting regulatory inspections and customer audits.
- Familiarity with equipment qualification and computerized
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Equal Opportunity Employer:Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
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