Manufacturing Engineer

Manufacturing Engineer

Location: Warsaw, IN (100% Onsite)

Duration: 12-Month Contract (Potential Extension Based on Project Needs)/W2

About the Role

We are seeking a Manufacturing Engineer I to support a large-scale manufacturing expansion project focused on equipment installation, qualification, and validation. This role will play a key part in validating new and relocated manufacturing equipment, collaborating with cross-functional teams, and ensuring compliance with quality and regulatory standards.

The ideal candidate has experience in equipment qualification, process validation, and manufacturing environments, preferably within the medical device, pharmaceutical, or biotechnology industries.

Responsibilities

• Execute equipment qualification and process validation activities, including IQ/OQ/PQ protocols.
• Develop, execute, and document installation, operational, and performance qualification activities for manufacturing equipment.
• Support qualification and validation of CNC machining equipment and cleaning equipment.
• Create and process engineering change requests using Windchill or similar PLM/change management systems.
• Coordinate validation activities with Manufacturing, Quality, Maintenance, Engineering, and external contractors.
• Develop project plans and manage validation activities to support equipment installations and relocations.
• Analyze validation data using statistical tools such as Minitab.
• Ensure validation documentation complies with cGMP, FDA, and applicable quality system requirements.
• Identify project risks and proactively communicate status, issues, and solutions to stakeholders.
• Support continuous improvement initiatives related to manufacturing processes and validation activities.

Required Qualifications

• Bachelor's degree in Engineering or a related technical discipline (Mechanical, Biomedical, Industrial, Manufacturing, or similar).
• Minimum 2–3 years of experience in equipment qualification and/or process validation within a regulated manufacturing environment.
• Experience executing IQ, OQ, and PQ protocols.
• Knowledge of cGMP, FDA, and quality system requirements.
• Experience validating manufacturing equipment.
• Familiarity with statistical analysis tools such as Minitab.
• Experience working with cross-functional project teams.
• Strong technical writing, communication, and documentation skills.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.

Preferred Qualifications

• Experience in medical device, orthopedic, biotechnology, or pharmaceutical manufacturing.
• Hands-on experience with CNC machining equipment (e.g., Makino, Haas, Hermle, Schütte, grinders).
• Experience validating cleaning equipment and manufacturing processes.
• Familiarity with manufacturing processes such as machining, forging, molding, or heat treating.
• Experience with Windchill or other PLM/change management systems.
• Basic understanding of G-code, M-code, GD&T, engineering drawings, and CAD.
• Experience using Microsoft Project.

What You'll Bring

• Strong problem-solving and analytical skills.
• Ability to work independently while collaborating effectively across multiple functional teams.
• Excellent organizational and project coordination skills.
• Strong written and verbal communication abilities.
• Ability to prioritize tasks and thrive in a dynamic manufacturing environment.

Work Environment

• 100% onsite in Warsaw, Indiana.
• Opportunity to support a major manufacturing expansion involving the qualification and relocation of production equipment.
• Collaborative, team-oriented environment with exposure to cross-functional engineering and manufacturing operations.