Process Validation & Integration Engineer – Medical Packaging

Vonco Products, LLC; Indianapolis (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

Vonco Products, LLC in Indianapolis is seeking an Integration (Process Validation) Engineer to lead process validation and manufacturing integration activities for medical device packaging. This role includes developing protocols and ensuring compliance with FDA and ISO standards.

The ideal candidate has a Bachelor's degree in Engineering, 3+ years of experience in a regulated environment, and strong analytical and communication skills. This position offers opportunities for project management and cross-functional collaboration.

Qualifications

• 3+ years of engineering experience in a regulated manufacturing environment.
• Experience with process validation in regulated manufacturing.
• Strong technical writing and documentation skills.

Responsibilities

• Develop and execute IQ, OQ, and PQ validation protocols and reports.
• Lead validation activities for various manufacturing operations.
• Identify and implement process improvements focused on quality and efficiency.

Skills

Analytical skills

Problem-solving skills

Project management skills

Attention to detail

Effective communication

Education

Bachelor’s degree in Engineering or related field

Tools

Statistical analysis tools

EQMS systems

Job description

Vonco Products, LLC in Indianapolis is seeking an Integration (Process Validation) Engineer to lead process validation and manufacturing integration activities for medical device packaging. This role includes developing protocols and ensuring compliance with FDA and ISO standards.

The ideal candidate has a Bachelor's degree in Engineering, 3+ years of experience in a regulated environment, and strong analytical and communication skills. This position offers opportunities for project management and cross-functional collaboration.