Computer System Validation Engineer
TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.
TriLink BioTechnologies is seeking a Computer System Validation (CSV) Engineer responsible for managing the CSV program, including computer systems, equipment with computers or PLC controllers, and data integrity generated by the computer programs. Ensure compliance with applicable domestic and international standards and regulations.
•Develop validation plans, protocols, and reports for validation activities
•Execute validation protocols and interact with other functions to facilitate protocol execution as necessary
•Perform gap assessments of current computer systems to industry standards and develop plans to close gaps
•Work with global and local IT functions for validation of global computer systems that go across sites (e.g., MasterControl, NetSuite, etc.)
•Provide input in the global data integrity program for computer systems and lead various projects for implementation and maintenance of the program
•Coordinate validation activities across various departments and provide updates to management to ensure projects stay on track
•Oversee validation activities from contractors and vendors as necessary
•Develop processes and procedures for computer system validation and change control, including equipment with computers or PLC controllers
•Apply expertise in current computer validation requirements by industry standards and FDA to develop and implement compliant computer validation strategies.
•Demonstrate excellent interpersonal skills, including the ability to resolve conflicts using poise, diplomacy, and tact and the ability to interact with people of a wide
variety of backgrounds, levels of responsibility, and education levels
•Assure compliance with all in-house or external specifications to standards, such as ISO and GMP regulations
•Perform other duties as assigned
•Bachelor's Degree in Engineering or Computer Science
•A minimum of 5 years' experience in related field of work within the biotech or pharmaceutical industry.
•Experience developing plans, protocols, and executing computer validation projects in the biotech or pharmaceutical industries.
•Good understanding of computer system validation and computer system management in cGMP operations. Must have specific knowledge of computer validation
methodologies and principles.
•Understanding of Good Automatic Manufacturing Practices issue 5 (GAMP 5), 21 CFR Part 11, Annex 11, and other industry best practices is required.
TriLink BioTechnologies is a rapidly growing biotech firm in San Diego, CA, that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.
TriLink BioTechnologies is an EEO Employer.