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Senior Validation Engineer for Computer Systems

2 months ago

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

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

Location: King of Prussia (onsite)

Company: SK Pharmteco

The Computer System Validation (CSV) Engineer plays a crucial role in executing validation tasks for computer systems and software applications, ensuring adherence to regulatory standards, industry guidelines, and internal policies. This position entails 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 guidelines (e.g., GAMP 5).
  • Draft and review validation documentation, including validation plans, protocols, and reports.
  • Conduct and document risk assessments to pinpoint potential validation challenges and devise mitigation strategies.
  • Execute validation testing, including 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 support and recommendations for solutions.
  • Maintain thorough and accurate validation records and documentation.
  • Assist the CSV Manager in planning 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 enhance 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.
  • In-depth knowledge of regulatory standards and industry guidelines pertaining to CSV (e.g., FDA 21 CFR Part 11, GAMP 5, EU Annex 11).
  • Experience in validating various computer systems, including ERP systems, LIMS, MES, and other software applications.
  • Strong analytical and problem-solving abilities, with meticulous attention to detail.
  • Effective communication and interpersonal skills, with the capability to collaborate and build 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, with a proactive and results-driven 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 convey essential information regarding the scope of the job 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 that prohibits discrimination and harassment of any kind and provides equal employment opportunities to employees and applicants.