Project Compliance Engineer - SLC West

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Salt Lake City, United States, Utah, 84116

Job

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List.

Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

This position 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.

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

• 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.

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/

Experience:

• 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/Knowledge/Abilities:

• Computer proficiency with comprehensive working knowledge of MS Office products and systems such as SAP, Veeva, EDMS, Track Wise and other computer relational databases.
• Detail oriented with ability analyze information, create metrics…