Senior Manufacturing Engineer

Kindeva Drug Delivery•Maryland Heights, MO

1d•Onsite

About The Position

We are seeking an experienced Senior Manufacturing Engineer to lead technical operations and process optimization in our state-of-the-art Assembly, Inspection, and Packaging plant. In this critical role, you will drive manufacturing excellence for pharmaceutical products (sterile and non-sterile) while ensuring full compliance with cGMP, FDA, EMA, and other regulatory requirements. As a senior technical leader, you will be responsible for equipment performance, process robustness, continuous improvement, new product introductions (NPI), Tech Transfers in high-speed automated inspection, assembly and packaging lines.

Requirements

Bachelor’s degree in Mechanical, Chemical, or Industrial Engineering, or a related technical field; master’s degree preferred.
Minimum 6+ years of experience in pharmaceutical or biotechnology manufacturing, with at least 2 years in a Senior Engineer or equivalent role.
Strong experience in Assembly, Inspection, and Packaging of sterile injectables or complex drug-device combination products is required.
Proven track record with high-speed automated packaging lines, vision inspection systems, and serialization systems.
Deep knowledge of cGMP, validation principles (GAMP 5 – Risk Based approach to compliant GxP design and systems), and pharmaceutical regulatory requirements.
Experience with statistical process control (SPC), Design of Experiments (DOE), and root cause analysis tools (FMEA, Fishbone, etc.).
Proficiency in reading technical drawings (P&ID, mechanical layouts) and working with CAD software.
Familiarity with Track-and-Trace, 2D coding, and anti-counterfeiting technologies.
Strong leadership and project management skills.
Excellent technical writing and communication abilities.
Ability to thrive in a fast-paced, client-focused CDMO environment.

Nice To Haves

Lean Six Sigma Green Belt or Black Belt certification is highly desirable.
Experience supporting commercial manufacturing for large pharmaceutical clients.
Knowledge with integrated packaging systems such as feeders, labelers, cartoners, checkweighers, case packers, reject systems, vision inspection, and serialization/aggregation platforms preferred.
Previous experience in a multi-product CDMO facility.
Project management certification (PMP) or equivalent.

Responsibilities

Lead the design, qualification, and optimization of visual inspection, assembly, labeling, and packaging processes for vials, syringes, cartridges, auto-injectors, and other pharmaceutical delivery devices.
Develop and maintain process flow diagrams, equipment specifications, and critical process parameters (CPPs).
Identify and implement process improvements using Lean, Six Sigma, and data-driven methodologies to increase throughput, yield, and equipment effectiveness (OEE).
Lead capital and continuous improvement projects from concept through implementation, including scope definition, URS development, vendor engagement, FAT/SAT support, commissioning, qualification, and handoff to operations.
Troubleshoot complex manufacturing issues related to high-speed automation, vision systems, robotics, and serialization/track-and-trace systems.
Lead by example in safety, environmental, and compliance practices; identify and mitigate operational risks in manufacturing processes and equipment.
Author, execute, and review validation protocols (IQ/OQ/PQ, process validation, and computer system validation) for new and existing equipment.
Ensure all manufacturing processes remain in a validated state and comply with 21 CFR Parts 210/211, Annex 1, and ISO standards.
Support regulatory inspections (FDA, EMA, etc.) and internal audits as a subject matter expert (SME) for IAP processes.
Lead deviation investigations, CAPA implementation, and change control activities.
Serve as the primary manufacturing engineering lead for technology transfers and scale-up of new products into the IAP plant.
Collaborate with Process Development, Quality Assurance, and Regulatory Affairs to ensure manufacturability and compliance.
Support design for manufacturability (DFM) reviews during product development.
Evaluate, select, and implement new assembly, packaging and inspection technologies (e.g., automated visual inspection systems, high-speed labelers, cartoners, case packers).
Manage equipment reliability programs, including preventive maintenance optimization and spare parts strategy.
Work closely with Reliability, Maintenance and Automation Engineering teams on equipment uptime and performance.
Mentor and provide technical guidance to junior Manufacturing Engineers and technicians.
Lead cross-functional teams on major projects and Kaizen events.
Drive OEE improvement initiatives and cost reduction programs.
Prepare technical reports, presentations, and documentation for leadership and clients