Role Summary

The Computer Validation Specialist (CSV) will be engaged in coordinating validation efforts for computer systems, hardware and software, especially in the lab setting, to ensure process quality. The CSV Specialist responsibilities include managing computer validation project activities and creating computer system planning documents and testing protocols. The position is also responsible for reviewing test results and identifying areas for improvement and implementing changes. Other duties include providing technical expertise to team members and other departments while communicating the validation plan and creating protocols. This position is responsible for ensuring the systems and process are compliant with GxP, GAMP and Code of Federal Regulations.

This is an exempt position with no supervisory responsibilities. This person can sit at either our Norton Shores or Portage, MI location.

Role Responsibilities

• Work with QA management in development and implementation of efficient software/computer validation program for GLP environment
• Identify computerized systems validation needs through in-house assessments or by coordinating needs assessments to be conducted by external team
• Partner with business and validation team for site computer validation projects
• Development of Software/Computer validations protocols and final reports as well as to coordinate and perform activities per protocols
• Maintain site Master Validation Schedule and periodic review of validated systems.
• Assist QA in the process of auditing vendors of cGMP related software and hardware.
• Evaluate Vendor validations, adding company specific protocols as required to complete validation
• Provide technical council on issues and concerns regarding validation plans and protocol designs. Provide input on the design of the specifications and/or functional specification requirements for equipment’s facilities and systems
• Train company as needed on SOPs
• Other duties as assigned

Role Requirements

• Minimum: bachelors or equivalent
• Experience: 5-10 years’ experience in Computer System Validations
• Knowledge of GxP
• Level of proficiency necessary for competence in the position as identified by the department training website
• Knowledge of GLPs (21 CFR Part 11) and other federal regulations relating to information technology
• Advanced understanding of laboratory operations and data collection
• Ability to work effectively under time constraints

Behavioral Expectations

• Adaptability/Flexibility
• Conflict Resolution
• Critical Thinking
• Resilience

Special Requirements

• The person filling this position will spend approximately 80% in an office setting and 20% in the laboratory. There will be exposure to animal pathogens and chemicals. There will be handling of, and/or exposure to animal tissue and zoonotic organisms.
• Ability to don and wear personal protective gear, including N95 masks and respirators.
• Physical requirements: Ability to lift and carry up to 50lbs. Occasionally ascend/descend ladders and stairs.
• Ability to work beyond typical work schedule including but not limited to evenings, weekends, extended shifts with short notice.