Grifols Shared Services North America, Inc Engineer IV/ Sr. Engineer/ Staff Engineer in Clayton, North Carolina
Grifols is a global healthcare company whose mission is to improve the health and well being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.
We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.
Technically competent engineer who independently develops and implements solutions for day-to-day sterile filling operations issues. Provides maintenance support and reliability improvements. Develops and executes continuous improvement projects.
Primary responsibilities for role
Troubleshoots equipment, automation, and process issues and implements process solution/improvements.
Responsible for sterile filling equipment and supporting utility condition assessments
Manages equipment locations, assets, and spare parts in maintenance management system
Responsible for maintaining equipment maintenance manuals, P&IDs, and other equipment information in Merdian
Coordinates maintenance and reliability improvements on routine day to day activities.
Executes small projects while maintaining project budgets and schedules.
Understands end user requirements and converts requirements into functional and efficient designs.
Communicates and collaborates with other team members and departments
Performs engineering calculations.
Provides qualification and validation assistance when necessary.
Nights and weekends as required to support 24/7 filling operations
Works closely with Grifols Engineering in North America and Spain to support and maintain equipment
5% travel Knowledge, Skills, and Abilities
Knowledge of aseptic unit operations and filling equipment; specifically autoclaves, lyophilizes, etc.
Knowledge of industrial and clean utility systems including HVAC, Steam, WFI, and compressed gases
Experience engineering within regulated environments (i.e. FDA, cGMP, etc.) required
Strong communication skills
Experience with project development, start-up, commissioning and validation as well as leading and supporting factory acceptance tests and site acceptance
Some knowledge of packaging equipment
Some knowledge of programmable logic controllers
Bachelor's Degree in Engineering or Related Field plus applicable experience for level. See below levels (posting at 3 levels)
M07 - Engineer IV
- Minimum 4 years experience in biotech or engineering company.
M08 Senior Engineer
- Minimum 5 years experience in biotech or engineering company
M09 Staff Engineer
Minimum 5 years experience in biotech or engineering company
Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. Stands for 2-4 hours per day. Frequent movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Occasionally bends and twists neck and waist. Frequent foot movements. Color perception/discrimination, depth perception and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Frequently performs routine tasks by following a set of written or oral instructions/procedures.
Learn more about Grifols at http://www.grifols.com/es/web/international/home