Validation Specialist

3 weeks ago


College Station, Texas, United States CPMNA Full time
Validation Specialist - Computerized Systems

We are seeking an experienced Validation Specialist - Computerized Systems to join our team at CPMNA. The successful candidate will be responsible for ensuring the compliance of our computerized systems with regulatory requirements, such as 21 CFR Part-11 and Annex-11 Data Integrity.

Key Responsibilities:

  • Develop and implement validation protocols for computerized systems, including DCS, SCADA, and BMS systems.
  • Conduct reviews and approval of SDLC deliverables, including software development lifecycle documentation.
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements and industry standards.
  • Provide training and support to colleagues on regulatory compliance matters.
  • Participate in regulatory audits and inspections as a subject matter expert.

Requirements:

  • Master's degree in Computer Science, Life Sciences, Engineering, or similar discipline with three (3) years of experience in computer system validation activities in pharmaceutical, biotechnology, or related industry.
  • Bachelor's degree in Computer Science, Life Sciences, Engineering, or similar discipline with five (5) years of experience in computer system validation activities in pharmaceutical, biotechnology, or related industry.
  • Associate's degree in Computer Science, Life Sciences, Engineering, or similar discipline with seven (7) years of experience in computer system validation activities in pharmaceutical, biotechnology, or related industry.

Salary: $90,000 - $120,000 per annum, depending on qualifications and experience.



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