Process Validation Engineer I

Kindeva Drug Delivery • Maryland Heights, MO

121d • Onsite

About The Position

The Process Validation Engineer is part of the Manufacturing Science & Technology (MS&T) organization and supports 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. It works with Manufacturing, Quality, Process Development, Engineering, and Regulatory Affairs to ensure manufacturing processes are robust, compliant, and consistently produce high-quality products.

Requirements

• Bachelor's degree in Engineering, Pharmaceutical Sciences, Biotechnology, Life Sciences, or a related technical field.
• At least 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.

Nice To Haves

• Experience in sterile injectable, aseptic manufacturing, biologics, or combination products.
• Familiarity with visual inspection, assembly, labeling, serialization, and packaging operations.
• 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 systems.

Responsibilities

• Author and execute 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.
• Analyze validation data and perform statistical evaluations of process capability and performance.
• Support process risk assessments using tools such as FMEA and process mapping.
• Ensure validation activities comply with cGMP requirements and site procedures.
• Monitor and trend critical process parameters (CPPs) and critical quality attributes (CQAs).
• Generate CPV reports and evaluate process performance data to identify trends and improvement opportunities.
• Support investigations related to process deviations, out-of-trend results, and process excursions.
• Participate in implementing and verifying corrective and preventive actions (CAPAs).
• Support technology transfer 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.
• Use statistical tools and process data to identify process variability and optimization opportunities.
• Support process robustness initiatives and operational excellence projects.
• Assist in developing process control strategies and process capability assessments.
• Participate in root cause investigations and implement process improvements.
• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level