Manufacturing Engineer
Kindeva Drug Delivery
Manufacturing Engineer
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.
Key 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.
Qualifications & 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.
Preferred Qualifications
- 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
What We Offer
- Competitive base salary + performance bonus
- Comprehensive benefits package (health, dental, vision, 401k, etc.)
- Structured mentorship and professional development programs
- Exposure to cutting-edge pharmaceutical manufacturing technologies
- Clear career progression path toward Senior Manufacturing Engineer roles
- Collaborative and supportive work culture
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