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Senior Process Engineer - Equipment

Catalent · Harmans, MD

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Role summary

Catalent seeks a Senior Process Engineer - Equipment for its FDA-licensed gene therapy manufacturing facility in Maryland. The role involves equipment onboarding, commissioning, qualification, and maintenance support for biopharmaceutical production using single-use systems in a cleanroom environment.

What they're looking for

  • Bachelor's degree in chemical or mechanical engineering
  • At least 4 years of GMP or biopharma maintenance and engineering experience
  • Expertise in mechanical, electrical, and automation systems for bioprocess equipment
  • Experience with sterile manufacturing, aseptic filling, and isolator technology
  • Working knowledge of cGMP regulations and pharmaceutical engineering standards
  • Proficiency in GMP documentation practices and quality system management
  • Strong problem-solving and cross-functional collaboration skills

What you'll be doing

  • Analyze and implement engineering solutions to improve equipment reliability and manufacturing performance
  • Troubleshoot and optimize bioprocess, fill/finish, packaging, and laboratory equipment and control systems
  • Lead engineering projects including commissioning, qualification, and validation activities
  • Manage preventive and corrective maintenance programs using CMMS and develop SOPs
  • Support GMP-compliant quality activities including change controls, deviations, and failure investigations
Compensation$94,000 – $128,000 base plus bonus

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Date posted9 days ago
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