Fill Finish and Packaging Engineer - Trinity Consultants - Advent Engineering : Job Details

Fill Finish & Packaging Engineer

PLEASE NOTE WE DO NOT WORK ON C2C BASIS

Open to Candidates with citizenship from the US and Canada

ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Head-quartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.

ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.

The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.

This is an outstanding opportunity to join our growing team!

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