Manufacturing Engineer Ii

Position summary

Key responsibilities

• Own and review ECRs, ECNs, routers, 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 residue and cleanliness acceptance criteria, sampling and test method selection, cleaning agent evaluation, worst-case/bracketing rationale, 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.

Required qualifications

• Bachelor's degree in Mechanical, Biomedical ,Manufacturing, Industrial, or related engineering field.
• Minimum 3 5 years of manufacturing engineering experience in a regulated production setting.
• Required: demonstrated working knowledge of the InfoPV system, including equipment qualification documentation, execution, and traceability within the system.
• Required: 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.