Manufacturing Engineer

The Manufacturing Engineer is responsible for supporting process readiness, process and product transfers, engineering changes, equipment activities, validation execution, work instruction development, and manufacturing system implementation. This position ensures efficient and compliant site operations within a regulated production environment.

• Own and review Engineering Change Requests (ECRs), Engineering Change Notices (ECNs), routers, Bill of Materials (BOM) updates, and work instructions.

• Walk processes to assess readiness, risks, and implementation needs.

• Support equipment installation, qualification (IQ/OQ/PQ), requalification, validation, relocation, and decommissioning activities.

• Support cleaning validation and cleaning process development, including criteria for residues and cleanliness, sampling and test method selection, cleaning agent evaluation, and periodic revalidation.

• Support packaging validation activities, including package integrity, seal strength and seal process validation, sterile barrier system qualification, distribution/transit simulation, shelf-life and aging studies, and labeling verification.

• Assist with protocol creation, execution support, deviation resolution, and report activities tied to transfers, validations, and manufacturing changes.

• Use Windchill to author, review, manage, and support engineering documentation and change activity.

• Own and execute InfoPV equipment qualification and validation activities, including protocol setup, documentation, execution support, record management, and traceability within the system.

• Develop, review, and maintain control plans, process flow diagrams, and pFMEAs to ensure manufacturing process consistency and compliance.

• Partner with Operations and Quality to improve flow, efficiency, and manufacturability.

• Bachelor's degree in Mechanical, Biomedical, Manufacturing, Industrial, or related engineering field.

• Minimum of 35 years of manufacturing engineering experience in a regulated production setting.

• Demonstrated working knowledge of the InfoPV system, including equipment qualification documentation, execution, and traceability.

• Strong hands‑on Windchill knowledge, including engineering documentation and change management (ECR/ECN, BOM, routers).

• Working knowledge of equipment qualification/validation processes and documentation (IQ/OQ/PQ, requalification).

• Experience with cleaning validation principles, acceptance criteria, and supporting documentation.

• Experience with packaging validation, including seal process validation, package integrity testing, and distribution/aging studies.

• Experience with process changes, documentation, and cross‑functional implementation.

This role operates in a regulated production environment, requiring hands‑on proficiency with systems such as Windchill and InfoPV. The work involves collaboration with cross‑functional teams to ensure efficient and compliant manufacturing processes.

This is a Contract position based out of Warsaw, IN.

The pay range for this position is $40.00 - $51.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job‑related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness,…