Manufacturing Specialist - Fill/finish

Catalent

Harmans, Maryland, United States
Base: $105,000 to $120,000 annually; bonus: annual...
3+ years aseptic filling experience
Gmp and fda regulatory knowledge
Lean six sigma methodology application
This role supports day-to-day fill/finish manufacturing activities as a Subject Matter Expert within a state-of-the-art CGMP gene therapy campus

Job Summary

  • This role supports day-to-day fill/finish manufacturing activities as a Subject Matter Expert within a state-of-the-art CGMP gene therapy campus.
  • The incumbent will lead continuous improvement assessments, apply Lean Six Sigma methodologies, and manage root cause investigations to ensure quality remediation.
  • Catalent offers comprehensive benefits including medical, dental, vision, 401K from day one, 152 hours of PTO, and 8 paid holidays.

Matching Summary

This role supports day-to-day fill/finish manufacturing activities as a Subject Matter Expert within a state-of-the-art CGMP gene therapy campus.

Salary

Base: $105,000 to $120,000 annually; Bonus: Annual bonus when eligible; Benefits: Medical, Dental, Vision, 401K, 152 hours PTO, 8 paid holidays

Skills & Requirements

Must-have

  • 3+ years aseptic filling experience
  • GMP and FDA regulatory knowledge
  • Lean Six Sigma methodology application
  • Root cause investigation and CAPA authoring
  • Experience with peristaltic/piston pump fillers

Nice-to-have

  • MES, EMS, MRP, LIMS system proficiency
  • Basic programming skills
  • Cross-functional team leadership
  • Electronic batch record implementation
  • Strong technical writing abilities

Key Requirements

  • Master's degree in scientific/engineering field OR Bachelor's with 4+ years
  • Associate's or HS diploma with 5+ years aseptic filling in GMP
  • Knowledge of EU Annex 1 and FDA regulations
  • Experience operating automated packaging lines and autoclaves
  • Proven ability to author deviations and change controls

Work Rights

Not specified

Tailored Resume

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