Senior Facilities Engineer

Catalent • Harmans, MD

1d

About The Position

The Sr. Facilities Engineer will provide engineering support of critical utilities used in GMP manufacturing. This individual will work with the Facilities and Engineering teams, as well as Manufacturing to design and scale-out manufacturing capability and support manufacturing operations, as well as improve existing manufacturing operations and facilities. Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Requirements

• Bachelor’s degree in Chemical, Biochemical or Mechanical Engineering, Biotechnology or equivalent and Five (5) years of related experience
• Associate’s degree in Chemical, Biochemical or Mechanical Engineering, Biotechnology or equivalent and Seven (7) years of related experience
• In-depth understanding and knowledge of Clean Utility Systems including; WFI generation and distribution, purified water generation and distribution, clean steam generation and distribution, HVAC for clean rooms, and clean gas generation and distribution

Responsibilities

• Lead the design, implementation, and commissioning for new utility equipment and modifications to existing utility equipment and facilities within GMP Manufacturing
• Author and review protocols, standard operating procedures, and provide technical assessment and approval for engineering and process changes
• Work with industry /consultants to create design specifications, P&ID drawings, GA drawings, User Requirements, Functional Specifications and automation control strategies.
• Write and review technical documentation such as protocols and reports for FATs, SATs, and IQ/OQ/PQ testing.
• Provide technical solutions to facility and utility equipment problems
• Perform investigations of manufacturing deviations and anomalies related to failure of facility systems.
• Perform utility monitoring, utility capability, statistical analysis and quality engineering activities.

Benefits

• Competitive medical benefits and 401K
• 152 hours PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment
• Opportunity to work on Continuous Improvement Processes
• Catalent offers rewarding opportunities to further your career!
• Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world.
• Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
• Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.
• Join us in making a difference. personal initiative. dynamic pace. meaningful work.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees