Process Validation Engineer I

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around 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 Responsibilities:Process Validation & PPQAuthor and execute Process Performance Qualification (PPQ) protocols reports sampling plans and validation development and implementation of process validation strategies in accordance with FDA EMA and ICH validation activities with Manufacturing Quality Control Quality Assurance and Engineering validation data and perform statistical evaluations to assess process capability and process risk assessments using tools such as FMEA and process validation activities are completed in compliance with cGMP requirements and site 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 investigations related to process deviations out-of-trend results and process in implementation and verification of corrective and preventive actions (CAPAs).Technology Transfer SupportSupport technology transfer activities for new products process improvements and manufacturing scale-up in developing process descriptions manufacturing instructions and transfer in process fit-gap assessments and risk equipment qualification facility readiness assessments and process characterization Monitoring & Continuous ImprovementUtilize statistical tools and process data to identify process variability and opportunities for process robustness initiatives and operational excellence in development of process control strategies and process capability in root cause investigations and implementation of process & CompliancePrepare review and maintain validation protocols reports technical assessments and supporting documentation is accurate complete and change control assessments and validation impact in internal audits customer audits and regulatory inspections as a subject matter expert for assigned validation -Functional CollaborationWork closely with Manufacturing Quality Process Development Regulatory Affairs and Engineering technical support for manufacturing operations and process with regulatory submissions and responses related to process validation and manufacturing process validation findings and recommendations to cross-functional teams and site QualificationsBachelors degree in Engineering Pharmaceutical Sciences Biotechnology Life Sciences or related technical field.5 years of experience in pharmaceutical biopharmaceutical or sterile injectable with process validation PPQ execution CPV technology transfer or manufacturing support knowledge of cGMP regulations FDA guidance and ICH validation technical writing analytical and problem-solving with statistical analysis tools such as JMP Minitab or equivalent Qualifications:Experience in sterile injectable aseptic manufacturing biologics or combination with visual inspection assembly labeling serialization and packaging operations of process characterization process capability analysis and statistical process supporting technology transfer supporting regulatory inspections and customer with equipment qualification and computerized#JJ#LI-Onsite