Duties:
Position summary
The Manufacturing Engineer supports process readiness, process and product transfers, engineering changes, equipment activities, validation execution, work instruction development, and manufacturing system implementation to ensure efficient and compliant site operations. This role requires a minimum of 3–5 years of manufacturing engineering experience in a regulated production environment, with required hands-on proficiency in Windchill and the InfoPV system, along with process transfer experience, equipment qualification/validation knowledge (IQ/OQ/PQ), cleaning, Biological upgrade and packaging validation knowledge, equipment upgrade/change control experience, Gage R&R experience, control plan knowledge, and Vault DMR update knowledge.
Skills:
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.
Education:
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.
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