Senior Facilities Engineer

Catalent Pharma Solutions; Harmans (MD); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Sr. Facilities Engineer to support critical utilities in GMP manufacturing. This role involves leading the design and implementation of utility systems, ensuring compliance with quality standards, and resolving facility-related issues. You will collaborate with engineering teams to enhance manufacturing operations and contribute to continuous improvement processes. Join a dynamic, fast-paced environment where your expertise will directly impact the development of life-saving treatments. This is a unique opportunity to be part of a mission-driven organization dedicated to improving patient outcomes worldwide.

Benefits

Competitive medical benefits

401K

152 hours PTO

8 Paid Holidays

Dynamic work environment

Continuous Improvement Processes

Qualifications

• 5+ years of experience in engineering support of critical utilities in GMP manufacturing.
• In-depth knowledge of Clean Utility Systems including WFI and HVAC.

Responsibilities

• Lead design and commissioning of new utility equipment in GMP Manufacturing.
• Author and review protocols, SOPs, and provide technical assessments.

Skills

Clean Utility Systems

GMP Manufacturing

Statistical Analysis

Technical Documentation

Education

Bachelor’s degree in Chemical, Biochemical or Mechanical Engineering

Associate’s degree in Chemical, Biochemical or Mechanical Engineering

Tools

P&ID drawings

GA drawings

Automation control strategies

Job description

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 is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

The role:

• 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.

The candidate:

• 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.

Why you should join Catalent:

• 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.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.