Reliability Engineering Manager — GMP Biopharma (Onsite)

Catalent; Harmans (MD); On-site; USD 145,000 - 165,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition reimbursement

Competitive PTO + 8 holidays

Diversity and inclusive culture

Career growth opportunities

Job summary

Catalent in Harmans, MD is seeking a Reliability Engineering Manager to safeguard plant reliability and drive continuous improvement across maintenance programs, supporting Phase 3 through commercial manufacturing of biopharma products.

You will lead analysis methods such as RCA, FMEA, SPC and Weibull, manage budgets, and ensure cGMP compliance while partnering with Manufacturing, Engineering, and MS&T. Qualifications include a BS in engineering and 5 years in reliability engineering.

Qualifications

• BS degree in engineering required; chemical or mechanical preferred.
• 5 years of reliability engineering experience.
• Proven ability in mechanical and electrical design, repairs, and maintenance.
• Experience with problem-solving and continuous improvement.
• Clear English communication skills, written and spoken.
• Experience with RCA, FMEA, SPC, reliability modeling, FTA, Weibull, and Six Sigma tools.
• Strong technical writing and ability to meet deadlines.

Responsibilities

• Lead Equipment Reliability Program development, including preventive/predictive maintenance.
• Provide reliability input to the Business Continuity Plan to mitigate risks.
• Direct solutions for recurring equipment failures using data-driven methods.
• Oversee RCA and FMEA to ensure effective corrective actions.
• Collaborate with Manufacturing, Engineering, and MS&T to evaluate asset performance.
• Provide technical leadership to manufacturing and engineering teams.
• Manage cost-benefit decisions on repair vs replace or redesign.
• Lead equipment upgrades and reliability improvement initiatives under change control.
• Manage requisitions and oversee operating and capital budgets.
• Ensure compliance with safety, quality and cGMP requirements.

Skills

Mechanical design

Electrical design

Maintenance & repair

Root Cause Analysis

Failure Mode and Effects Analysis

Statistical Process Control

Reliability modeling

Fault Tree Analysis

Weibull Analysis

Six Sigma tools

Education

Bachelor of Science in Engineering

Chemical or Mechanical Engineering degree preferred

Job description

Catalent in Harmans, MD is seeking a Reliability Engineering Manager to safeguard plant reliability and drive continuous improvement across maintenance programs, supporting Phase 3 through commercial manufacturing of biopharma products.

You will lead analysis methods such as RCA, FMEA, SPC and Weibull, manage budgets, and ensure cGMP compliance while partnering with Manufacturing, Engineering, and MS&T. Qualifications include a BS in engineering and 5 years in reliability engineering.