Manufacturing Engineer

Kindeva•Maryland Heights, MO

5d•Onsite

About The Position

Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make We are seeking a motivated and detail-oriented Manufacturing Engineer to support technical operations in our Inspection, Assembly & Packaging plant. This is a great opportunity for an entry-level engineer looking to build a strong foundation in pharmaceutical manufacturing.

Requirements

Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Industrial Engineering, Biomedical Engineering, or a related technical discipline.
2+ years of experience in pharmaceutical, biotechnology, or regulated manufacturing environment (internships or co-op experience in manufacturing is highly valued).
Exposure to Assembly, Inspection, or Packaging processes is preferred but not required.
Basic understanding of cGMP principles and pharmaceutical regulatory requirements.
Strong analytical and problem-solving skills.
Familiarity with statistical tools, root cause analysis, and Microsoft Office (Excel, Word, PowerPoint).
Ability to read and interpret technical drawings and equipment manuals is a plus.

Nice To Haves

Internship or co-op experience in pharmaceutical manufacturing or packaging operations.
Knowledge of Lean Manufacturing or Six Sigma principles.
Familiarity with automated inspection systems, serialization, or high-speed packaging equipment.
Experience working in a cleanroom or GMP environment

Responsibilities

Support achievement of safety, quality, delivery, and cost objectives for operations.
Support the monitoring and optimization of assembly, visual inspection, labeling, and packaging processes for vials, syringes, cartridges, and other pharmaceutical products.
Assist in developing and updating process documentation, including SOPs, batch records, and process flow diagrams.
Collect and analyze production data to identify opportunities for improving yield, throughput, and Overall Equipment Effectiveness (OEE).
Participate in troubleshooting manufacturing issues related to automated packaging lines, vision systems, and serialization equipment.
Assist in the execution of validation protocols (IQ/OQ/PQ, process validation) for inspection, assembly and packaging equipment.
Support deviation investigations, CAPA implementation, and change control processes.
Help maintain equipment and processes in a validated state in accordance with cGMP, FDA, and EMA regulations.
Participate in internal audits and prepare documentation for regulatory inspections.
Collaborate with cross-functional teams (Process Development, Quality Assurance, and Production) to ensure smooth scale-up and successful product launches.
Track actions, timelines, and deliverables to support project execution and site priorities.
Support equipment qualification, preventive maintenance, and calibration activities.
Work with senior engineers and maintenance teams to improve equipment reliability and uptime.
Learn and support the operation of high-speed automated inspection systems, assembly and packaging lines.
Participate in Lean and continuous improvement initiatives (Kaizen events, 5S, etc.).
Prepare technical reports and presentations as required.
Support daily production floor activities and provide engineering support during manufacturing campaigns.