Project Compliance Engineer - SLC West

Role Summary

The Project Compliance Engineer - SLC West is responsible for the development, creation and management of GMP documents (change controls and related tasks, SOPs, PMs, periodic reviews, qualification protocols/reports) in support of Engineering and Maintenance. The role ensures documents and activities are managed to completion by assigned dates, updated, trained, and effective in alignment with department needs. This position supports multi‑discipled teams in developing GEL documents for equipment acquisition and installation/implementation, including CER creation in Planisware and funding through SAP, and provides requisite documentation for equipment and process changes to increase efficiency and capacity.

Responsibilities

• Develop project timelines based on input from end users and suppliers, and manage projects to meet schedules.
• Interface with stakeholders/departments to lead installation and qualification of new equipment and upgrades.
• Create and execute “procurement only” site projects.
• Assist stakeholders in the development of new production areas.
• Contribute to Qualification Protocols, SOPs and PMs for new equipment and production processes.
• Perform and/or support qualification of new and modified equipment.
• Write and execute change controls for new and existing equipment.
• Direct or oversee the work of project team members and junior personnel as needed.
• Complete training requirements and maintain compliance with assignments.
• Maintain work areas and perform job functions safely and efficiently in accordance with policies, cGMPs, SOPs and Batch Records.
• Perform additional related duties as assigned.

Qualifications

• Required: Bachelor’s Degree in Science/Engineering and a minimum of 7 years of relevant progressive experience (preferably in a manufacturing environment within pharmaceutical, medical device or nutraceutical industries).
• Required: Extensive knowledge and experience in change control processes.
• Required: Extensive knowledge and experience in electronic document management systems.
• Required: Experience in project management.

Skills

• Computer proficiency with MS Office and systems such as SAP, Veeva, EDMS, TrackWise and other relational databases.
• Detail oriented with ability to analyze information, create metrics and link to business objectives.
• Strong collaboration with co‑workers, management and external partners.
• Detailed knowledge of change control and applicable qualification and validation processes.
• Ability to work in a team, resolve conflicts, and influence and lead others, with or without direct supervisory authority.
• Self-directed with ability to organize and prioritize work.
• Effective written and oral communication and technical writing skills.
• Familiarity with engineering design principles as related to validation.
• Project management skills.
• Subject matter expert on tablet compression equipment and process.

Education

• Bachelor’s Degree in Science/Engineering (as required for the role).