Project Compliance Engineer - SLC West

Role Summary

This position is responsible for development, creation and management of GMP documents (change controls and child tasks, SOPs, PMs, periodic reviews, qualification protocols/reports in support of Engineering and Maintenance). This role will ensure that all documents and activities are managed to completion by their assigned dates, and otherwise updated, trained, and effective in alignment with the department needs. This position will support multi-disciplined teams in the development of GEL documents for equipment acquisition and the installation/implementation process. The acquisition responsibility includes but is not limited to the creation of CERs in Planisware and their funding through SAP. This position will also support Engineering and Maintenance with the requisite documentation for making equipment and process changes to increase efficiency and capacity.

Responsibilities

• Responsible for developing project timelines based on input from end users as well as suppliers, then manages projects to meet established schedules.
• Responsible for interfacing with relevant stakeholders/departments to lead the installation and qualification of new equipment and upgrades to existing equipment.
• Responsible for creation and execution of “procurement only” site projects.
• Responsible for assisting relevant stakeholders/departments in the development of new production areas.
• Responsible for contributing to Qualification Protocols, SOPs and PMs in support of all new equipment and production processes.
• Responsible for performing and/or supporting the qualification of new and modified equipment.
• Responsible for writing and execution of change controls for new and existing equipment.
• Responsible for directing or overseeing the work of project team members and junior personnel as needed.
• Responsible for completing all training requirements and maintaining compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.

Qualifications

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

Skills

• Computer proficiency with comprehensive working knowledge of MS Office products and systems such as SAP, Veeva, EDMS, TrackWise and other computer relational databases.
• Detail oriented with ability analyze information, create metrics and articulate the link to business needs/objectives.
• Interact positively and collaborate with co-workers, management and external partners.
• Detailed knowledge and experience with change control and applicable qualification and validation processes.
• Ability to work in a team environment through conflict resolution and negotiations, influence and lead others with and/or without direct supervisory authority.
• Self-directed with ability to organize and prioritize work.
• Communicate effectively with strong 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 (minimum 7 years of relevant progressive experience in a pharmaceutical/manufacturing environment).