Sr. MS&T Process Engineer II

Kindeva Drug Delivery•Maryland Heights, MO

2d•Onsite

About The Position

The Sr. MS&T Engineer II serves as a technical leader within the Manufacturing Science & Technology (MS&T) organization, supporting sterile injectable drug product manufacturing, technology transfer, process validation, and lifecycle process management within a Contract Development and Manufacturing Organization (CDMO). This role is responsible for providing scientific and technical expertise across visual inspection, assembly, labeling, serialization, and packaging operations for clinical and commercial products. The position leads cross-functional initiatives including process development, process characterization, process performance qualification (PPQ), continued process verification (CPV), and technology transfer activities to ensure robust, compliant, and efficient manufacturing processes. The Sr. MS&T Engineer II authors and executes validation strategies, analyzes complex manufacturing and process data, supports investigations and change controls, and drives continuous improvement initiatives across manufacturing operations. As a Subject Matter Expert (SME), the individual collaborates closely with clients, Manufacturing, Quality, Engineering, Validation, Regulatory Affairs, and Project Management teams to successfully introduce new products, optimize existing processes, and maintain compliance with FDA, EU GMP, Annex 1, and global regulatory requirements. The role requires strong technical expertise in sterile injectable manufacturing, visual inspection, assembly, and packaging operations, along with exceptional communication, project management, and problem-solving skills.

Requirements

B.S. in Science or Engineering
7+ years of equivalent job experience.
Strong leadership skills; high level of personal/departmental accountability and responsibility.
Strong understanding of process design principles.
Experience with drug product manufacturing processes development, process scale-up and optimization.
Ability to perform well under tight timelines and excellent decision-making quality under pressure is desired.
Ability to manage multiple priorities and tasks in a dynamic environment.
Experience supporting sterile injectable visual inspection, assembly, labeling, and packaging operations in a pharmaceutical manufacturing or CDMO environment.
Knowledge of automated and manual visual inspection systems, defect classification, AQL methodologies, and inspection qualification requirements.
Experience with technology transfer, process validation (PPQ), CPV, and equipment qualification activities associated with packaging and inspection operations.
Familiarity with serialization, aggregation, labeling compliance, and secondary packaging requirements for commercial pharmaceutical products.
Strong understanding of FDA, EU GMP, Annex 1, and industry expectations related to sterile injectable inspection and packaging processes.

Responsibilities

Act as key technical lead for process development. Independently design and manage studies for process development, process optimization, scale-up, manufacturing records and technology transfer.
Serve as the technical lead for sterile injectable visual inspection, assembly, labeling, and packaging process validation activities, including equipment qualification support, process characterization, and continued process verification.
Independently design studies for evaluating the robustness of the manufacturing process. These studies will serve as a baseline for the further process validation activities.
Provide technical oversight and support for manual and automated visual inspection processes, including defect library development, inspection qualification studies, AQL implementation, false reject analysis, and continuous process improvement initiatives
Lead technology transfer activities for inspection, assembly, and packaging operations from clients and development sites into commercial manufacturing, ensuring successful process implementation and regulatory compliance.
Develop and execute process validation strategies for inspection, assembly, labeling, cartoning, serialization, aggregation, and secondary packaging processes in accordance with FDA, EU GMP, and client requirements.
Author and review protocols, reports, risk assessments, manufacturing instructions, and validation documentation supporting packaging and inspection equipment, processes, and technology transfers.
Perform statistical analysis and trending of inspection and packaging process performance data to identify opportunities for process optimization, defect reduction, yield improvement, and enhanced operational efficiency.
Support deviation investigations, CAPAs, change controls, nonconformance evaluations, and root cause investigations associated with inspection, assembly, and packaging operations.
Collaborate with Manufacturing, Quality Assurance, Engineering, Supply Chain, Validation, and Regulatory Affairs teams to ensure successful execution of clinical and commercial packaging programs.
Act as Subject Matter Expert (SME) for inspection, assembly, and packaging equipment including vision systems, leak detection systems, labeling equipment, cartoners, serialization platforms, and automated packaging lines.
Represents MS&T department as subject matter expert routinely in meetings/conference calls with clients
Works with client’s lead technical staff, department management and senior management to evaluate complex technical details pertaining to the project and defines the scope of the project.
Function as the Subject Matter Expert (SME) for Manufacturing processes and Technical Transfer of new products in regard to process development.
Execute experiments to support the development and characterization of new manufacturing processes.
Makes recommendations to the business development team regarding pricing and project studies and assist in preparation of project proposals.
Support implementation and lifecycle management of Continued Process Verification (CPV) programs for inspection, assembly, and packaging processes through monitoring, trending, and periodic product reviews.
Provide technical guidance and training to manufacturing personnel on inspection standards, packaging processes, defect identification, process controls, and new product introductions.
Support client audits, regulatory inspections, and customer technical discussions related to sterile injectable inspection, assembly, and packaging operations.