FDA-Regulated Manufacturing

FDA-Regulated Manufacturing at Dexian FDA-Regulated Manufacturing at Dexian in LAKE STATION, Indiana Posted in 1 day ago.

Type:

full-time

Job Description:

Job Title:

Manufacturing Engineer II |

Medical Device Duration:

6 months

Location:

Gary, IN 46406

Pay Rate:

$40.00 - $43.00 hourly on W2

Industry:

Medical Device Manufacturing We are seeking a Manufacturing Engineer II to support manufacturing operations within a highly regulated medical device manufacturing environment. This role requires hands-on experience with equipment and process validation, production support, and collaboration with cross-functional teams to ensure efficient and compliant manufacturing processes. Key Responsibilities Support daily manufacturing operations and troubleshoot production-related issues. Execute and support equipment and process validations (IQ/OQ/PQ). Develop, review, and execute validation protocols and reports. Work closely with Manufacturing, Quality, Operations, and Engineering teams. Support continuous improvement initiatives to enhance manufacturing efficiency and product quality. Participate in change control, risk assessments, and quality system activities. Ensure compliance with FDA regulations, GMP requirements, and internal quality standards. Analyze manufacturing data and recommend process improvements. Required Qualifications Bachelor's degree in Engineering or a related technical discipline. 2+ years of hands-on Manufacturing Engineering experience (1.5+ years may be considered with strong validation experience). Experience in a regulated manufacturing environment, preferably medical devices. Direct experience with

IQ/OQ/PQ

validation activities. Experience supporting manufacturing floor operations and production processes. Understanding of FDA regulations, GMP, change control, and quality systems. Strong problem-solving and communication skills. Ability to work effectively in a cross-functional team environment. Preferred Qualifications Medical device manufacturing experience. Experience with equipment qualification and process validation. Exposure to CAPA, root cause analysis, and continuous improvement initiatives. Experience preparing validation documentation, protocols, and reports. Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions.

Visit https:

//dexian.com/ to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.