PLEASE NOTE WE DO NOT WORK ON C2C BASIS
Open to Candidates with citizenship from the US and Canada
Role Summary
We're seeking an experienced and hands-on engineering professional to support the design, implementation, and documentation of equipment and processes for automated syringe assembly and packaging. This position will contribute to cross-functional technical transfer initiatives, process optimization, and documentation development in a regulated environment.
Documentation & SOP Development
- Author and revise SOPs for flexible operating parameters and process requirements
- Draft SOPs and six Work Instructions (WIs) for recipe development
- Update Engineering Equipment Assessment SOPs to ensure alignment with process requirements
- Perform technical writing tasks including regulatory document reviews, specifications, and training content creation
Operational & Material Coordination
- Support onboarding of materials and vendors into relevant systems
- Coordinate material movement and inventory management activities with Procurement, Warehouse, and Operations
- Prepare and process move order requests and onboarding documentation
🎓 Qualifications & Skills
- Bachelor's degree in Engineering or a related technical field (preferred)
- Min 3 years experience in regulated manufacturing environments (e.g., pharmaceutical, biotech, medical devices)
- Proficiency in SOP development and technical writing
- Strong data analysis and cross-functional collaboration skills
- Familiarity with equipment qualification, process validation, and packaging automation