Position Summary | The CSV Technician will manage electronic data in a regulated manufacturing/laboratory/clinical environment in compliance with FDA 21 CFR 11 or other regulatory guidelines using the GAMP lifecycle framework, administer the BSM help desk, and provide technical assistance for network applications for both new and existing systems at BSM. |
Duties and Responsibilities | - Write, review, and approval of validation SOPs and documentation
- Maintain accurate validation documentation
- Train other staff members on the correct use of computerized systems in line with protocols and regulations
- Keep up to date with advances in the field and, in particular, the regulatory requirements
- Involvement in review and updating of validation documentation
- Review and analyze validation data – compiling reports when required
- Recommendation of process upgrades and improvements in efficiency
- Implementation of such improvements
- Involvement in both internal audits and external inspections as required
- Manage Service Desk requests through support ticket generation, tracking and resolution utilizing hands on or remote support.
- Install, configure, and maintain computer hardware such as desktops, laptops, printers, and peripherals. Troubleshoot hardware failures and coordinate repairs or replacements as necessary.
- Assist with the installation, configuration, and troubleshooting of software applications. Provide guidance to users on software usage and best practices.
- Assist in coordinating activities with technology vendors and supporting technology contractors to design, setup or troubleshoot systems.
- Maintain organized records of company technology related documents, software licenses and equipment.
- Ensure compliance of corporate policies and standard operating procedures (SOPs) and participate in the development of plant specific SOPs for all IT activities.
- Assist with the administration and maintenance of Plant manufacturing systems.
- Strictly adhere to security policies and procedures to safeguard company data and IT infrastructure.
- Continuously strive to improve the company computerized systems with a focus on quality, timeliness and cost-awareness
- All other duties as assigned
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Regulatory Responsibilities | - Monitor and control security of company computerized systems, assess 21 CFR Part 11 compliance and respond with necessary corrective actions
- Ensure BSM IT/IS systems are operating efficiently and in compliance with FDA regulations and BSM approved procedures
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Supervisory Responsibilities | |
Experience | - Two (2) years of GMP experience, specifically with GxP computerized system applications.
- Two (2) years related technology experience or combination of education and work experience, may be concurrent with GMP experience requirement above.
- IT related certifications preferred
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Education | - Minimum of High School Diploma
- Associates degree preferred
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Knowledge, Skills & Abilities | - Proficient in MS Office applications (including Word, Excel, Powerpoint and Outlook), Windows OS, basic networking devices
- Solid understanding of the variety of GxP computerized system applications
- Solid understanding of Good Manufacturing Practice (GMP) rules and regulations
- Familiarity with Active Directory, Azure, MS Exchange, MS Teams is required
- Knowledge of RJ45 wiring required
- Good customer service skills
- Familiarity with databases and SQL software is preferred
- Well-organized
- Proficient at troubleshooting
- Attention to detail while executing multiple tasks, maintaining accurate records and files
- Ability to manage timelines to meet assigned goals
- Maintain control and confidentiality of documents and information
- Ability to work independently
- Ability to communicate in a professional manner and work in a fast-paced environment
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Physical Requirements | - Use of standard office equipment with or without reasonable accommodation(s)
- Ability to remain stationary for prolonged periods of time
- Walk between work areas
- Lift up to 10lbs. frequently and up to 50 lbs. occasionally
- Perform low voltage wiring and wire running in confined areas
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