Senior Computer System Validation Specialist

1 week ago


King of Prussia, Pennsylvania, United States SK pharmteco Full time

Position: CSV Engineer (Level II and Level IV/Sr)

Company: SK Pharmteco

The Computer System Validation (CSV) Engineer plays a crucial role in overseeing validation processes for computer systems and software applications, ensuring adherence to regulatory standards, industry guidelines, and internal policies. This position involves the preparation of validation documentation, execution of validation testing, and collaboration with cross-functional teams to meet validation goals.

Key Responsibilities:

  • Implement CSV activities in compliance with regulatory standards (e.g., FDA, EMA, GxP) and industry best practices (e.g., GAMP 5).
  • Draft and evaluate validation documentation, including validation plans, protocols, and reports.
  • Conduct and document risk assessments to pinpoint potential validation challenges and devise mitigation strategies.
  • Carry out validation testing, which encompasses installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
  • Work collaboratively with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure effective validation of computer systems and software applications.
  • Identify and resolve validation issues, providing technical guidance and recommendations for solutions.
  • Maintain thorough and accurate validation records and documentation.
  • Assist the CSV Manager in organizing and coordinating validation projects to ensure timely completion and adherence to project schedules.
  • Stay informed about industry trends, regulatory updates, and best practices related to computer system validation.
  • Support preparation for regulatory inspections and audits, including presenting validation documentation and addressing inquiries.
  • Engage in continuous improvement initiatives to refine the CSV process.

Qualifications:

  • Level IV/SR- 5-8+ years of experience in computer system validation within the pharmaceutical, biotechnology, medical device, or related sectors.
  • Comprehensive understanding of regulatory requirements and industry standards pertinent to CSV (e.g., FDA 21 CFR Part 11, GAMP 5, EU Annex 11).
  • Experience with the validation of diverse computer systems, including ERP systems, LIMS, MES, and other software applications.
  • Exceptional analytical and problem-solving abilities, with a strong attention to detail.
  • Effective communication and interpersonal skills, capable of collaborating and building relationships with cross-functional teams.
  • Ability to manage multiple tasks concurrently and meet deadlines.
  • Proficiency in creating and maintaining validation documentation.
  • Familiarity with risk assessment and mitigation strategies.
  • Capacity to work independently and as part of a team, demonstrating a proactive and results-oriented approach.
  • Certification in computer system validation or quality management (e.g., ASQ, ISPE) is advantageous.
  • Bachelor's degree in Computer Science, Information Technology, Engineering, Life Sciences, or a related discipline.

This job description is designed to provide essential information regarding the scope of the role. It is not intended to be an exhaustive list of qualifications, responsibilities, and skills required. Additional duties may be assigned as necessary.

SK Pharmteco Inc. is an equal opportunity employer, committed to prohibiting discrimination and harassment of any kind, and providing equal employment opportunities to all employees and applicants.



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