Lead Computer System Validation Engineer

2 weeks ago

Albuquerque, New Mexico, United States curiate Full time

Position Overview:

The Senior CSV Systems Engineer plays a crucial role within the Quality department, focusing on the validation of computer systems in the pharmaceutical and biotechnology sectors.

Key Responsibilities:

  • Ensure that all routine tasks related to the validation of electronic systems are meticulously documented in line with company protocols and regulatory standards.
  • Generate and execute validation documentation to maintain systems in a validated state according to regulatory guidelines.
  • Collaborate with cross-functional teams to identify necessary validation deliverables for new systems or modifications to existing systems.
  • Conduct impact assessments and ensure compliance with electronic record and signature regulations.
  • Perform thorough evaluations of vendor protocols to ensure adherence to current regulations.
  • Work across various functional areas to enhance computer system validation processes, ensuring they are efficient and compliant.
  • Guide the development and review of specification documents.
  • Maintain an accurate inventory of applications and systems, ensuring all have updated security measures.
  • Conduct regular reviews and provide updates on project statuses and compliance metrics.

Qualifications:

  • Bachelor's degree in Engineering, Life Sciences, Information Technology, or a related field.
  • A minimum of seven years of experience in a cGMP regulated environment, specifically in computer systems validation.
  • Strong knowledge of FDA regulations and global compliance standards.
  • Proven ability to lead and mentor team members, fostering a collaborative work environment.

Other Requirements:

  • Successful completion of background checks and drug screenings.
  • Ability to adapt to changing priorities and manage multiple tasks effectively.
  • Excellent communication skills, both verbal and written, to document findings and escalate risks as necessary.

This position is integral to ensuring the integrity of data and system validation within the organization, contributing to the overall mission of improving patient outcomes through high-quality pharmaceuticals.

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