Validation Analyst I — GMP & Compliance Focus

Catalent Pharma Solutions

Kansas City (MO)

On-site

USD 60,000 - 80,000

Full time

7 days ago
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Benefits offered by this job

Career growth
Diversity & inclusion
Paid time off
Tuition reimbursement
Benefits from day one

Job summary

Catalent’s Kansas City facility is seeking a Validation Analyst I to join our team. You will support validation and qualification programs across manufacturing and laboratory disciplines, ensuring compliance with Catalent guidelines and regulatory requirements while managing validation deliverables onsite in Kansas City, MO.

The role requires a Bachelor's degree and at least 2 years of validation or related experience; strong writing and communication skills, and familiarity with GMP, ISPE

Qualifications

  • Bachelor's degree in Life Sciences, Engineering, or related field.
  • Minimum of 2 years of validation, engineering, or related experience.
  • Strong knowledge of validation, quality, and regulatory compliance.
  • Understanding of GMP, ISPE GAMP5, and FDA/MHRA-like regulations.
  • Clear verbal and written communication; strong analytical skills.

Responsibilities

  • Execute and summarize validation protocols for equipment and instrumentation qualification.
  • Collaborate with Site IT, Global IT, QA, and Manufacturing to manage deliverables.
  • Apply project management in procurement, integration, and implementation of software and instruments.
  • Participate in continuous improvement and validation policy development.

Skills

Project management
Regulatory compliance
Technical writing
MS Office
Six Sigma
PMP

Education

Bachelor's Degree in Life Sciences/Engineering

Tools

Word
Excel
PowerPoint
SharePoint

Job description

Catalent’s Kansas City facility is seeking a Validation Analyst I to join our team. You will support validation and qualification programs across manufacturing and laboratory disciplines, ensuring compliance with Catalent guidelines and regulatory requirements while managing validation deliverables onsite in Kansas City, MO.

The role requires a Bachelor's degree and at least 2 years of validation or related experience; strong writing and communication skills, and familiarity with GMP, ISPE

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