Essential Responsibilities
- Participates in implementation planning, qualification and/or validation of laboratory systems and software
- Authors and reviews validation deliverables (risk assessment, requirements specification, IQ/OQ/PQ, etc.)
- Contributes to the development and revision of Computer System Validation procedures and policies (validations, change control, data integrity), following 21 CFR Part 11, Annex 11, GxP, and GAMP
- Completes periodic reviews of validated computer systems
- Performs administrative tasks for specialized scientific applications and other corporate systems; this may include but is not limited to installation, configuration, and maintenance of application servers for laboratory systems
- Follows standard operating procedures (SOPs) including those for account management, systems configuration, change control, and incident handling
Additional Responsibilities
- At all times, protect the security and integrity of company systems
- Other duties as assigned
Minimum Preferred Qualifications: Education/Experience
- Bachelor’s degree in computer science/engineering, or a related field
- Not less than five (5) years’ experience supporting scientific and enterprise systems, including but not limited to: application servers, Active Directory, virtualized infrastructure, and cloud-based systems, preferably in a regulated laboratory or research organization
- Not less than three (3) years’ direct hands-on experience with computer systems validation
Minimum Preferred Qualifications: Skills
- Proficiency in Computer System Validation, following GxP regulations and GAMP guidelines
- Advanced knowledge of Active Directory, Entra ID, Office 365, VMware, and other enterprise technologies
- Exceptional customer service and problem-solving skills
- Excellent written and verbal communication skills
- Strong interpersonal skills to work with all levels of management and employees
- Strong organizational skills to perform and prioritize multiple tasks seamlessly while delivering high quality results in a timely manner
- Acute attention to detail
Supervision Received and Supervisory Responsibility
- Receives minimal direction regarding prioritization and approval of proposed technical solutions
- Works independently to resolve issues following established SOPs and best practices
- Supports junior technicians to assist with advanced or specialized needs
- No supervisory responsibility