Job Description

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

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