Computer Systems Validation Specialist

2 weeks ago


Lebanon, Indiana, United States BioSpace, Inc. Full time
Job Details

We are seeking a highly skilled Computer Systems Validation Specialist to join our team at BioSpace, Inc. in Lebanon, IN. As a key member of our quality assurance team, you will be responsible for ensuring the integrity of our computer systems and data in compliance with Good Manufacturing Practices (GMP) regulations.

Responsibilities:
  • Develop and implement computer system validation strategies to ensure compliance with GMP regulations.
  • Collaborate with cross-functional teams to identify and mitigate risks associated with computer system validation.
  • Provide technical leadership and guidance on data integrity and computer system validation best practices.
  • Conduct regular audits and assessments to ensure compliance with GMP regulations.
Requirements:
  • Bachelor's degree in Computer Science, Engineering, Mathematics, or a related field.
  • 1+ year of experience in computer system validation, data integrity, or a related field.
  • Strong understanding of GMP regulations and industry standards.
  • Excellent communication and interpersonal skills.
Preferred Qualifications:
  • Direct experience with Computer Systems Validation (GAMP5) and data integrity basic principles (ALCOA+).
  • Previous experience in GMP or GLP environments.
  • Demonstrated ability to influence quality peers, IT SMEs, and upper management.

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for computer system validation and data integrity, we encourage you to apply for this exciting opportunity.



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