Manufacturing Line Engineer

Job Description

Job DescriptionDescription:

RK Pharma Inc, a vertically integrated pharmaceutical company headquartered in NJ, is seeking an Manufacturing Line Engineer to work with our growing Manufacturing department as we scale towards commercial manufacturing in the next upcoming months. As a company focused on the development, manufacturing and sale of high quality and affordable generic pharmaceutical products worldwide we are looking for sharp, driven, self-directed individuals to help us grow our mid-stage start-up team.

This position is located in East Windsor, NJ and is required to be onsite.

Requirements:

If this sounds interesting to you, it’s probably because up to this point you have:

• Bachelor’s degree in Mechanical, Manufacturing, Industrial, Chemical, or Biomedical Engineering (Master’s preferred).
• 5+ years of experience in pharmaceutical, medical device, or high-volume regulated manufacturing environments.
• Proven track record in equipment installation, validation (IQ/OQ/PQ), and process optimization for aseptic or solid-dose production lines.
• Strong working knowledge of GMP, GDP, FDA, and ISO 13485 quality standards.
• Proficiency with CAD software (SolidWorks, AutoCAD) for production line design and modification.
• Experience with automation systems (PLCs, robotics, HMI, and machine vision inspection).
• Familiarity with process and cleaning validation, change control systems.
• Working knowledge of Lean Manufacturing, Six Sigma, and Continuous Improvement methodologies.
• Strong communication and cross-functional collaboration skills, including documentation and technical writing for regulatory compliance.

The main expectations and responsibilities for this position are:

• Provide technical support for manufacturing lines, ensuring reliable operation, GMP compliance, and minimal downtime.
• Lead equipment qualification (IQ/OQ/PQ) and process validation activities for new or modified equipment.
• Perform process monitoring and data analysis to identify performance trends and drive continuous improvement.
• Conduct technical review of batch records and support investigations of deviations or non-conformances.
• Implement process and technology enhancements to improve efficiency, quality, and safety.
• Support change control and audit readiness in collaboration with Quality and Validation teams.

If this sounds like something that is of interest to you, please don’t hesitate to apply to start a conversation.

We look forward to getting to know more about you and the skills you can bring to a company like RK Pharma Inc.