cGxP Network/Systems Team Lead
GENERAL SUMMARY OF POSITION:
The cGxP Network / Systems Administrator III leads the set up, configuration, and support for all networks, systems, and servers within an FDA regulated research and manufacturing environment. Develops and maintains all systems, applications, security, and network configurations. Troubleshoots LAN and WAN network performance issues and creates and maintains a disaster recovery plan. Recommends upgrades, patches, and new applications and equipment. Provides technical support and guidance to users. Ensures that MBL's IS solutions are consistent with organizational goals, industry best practices, and regulatory requirements, including but not limited to cGxP and 21 CFR part 11.Responsibilities
- Develops, monitors, maintains, and tests all networks, systems, servers, UPS systems, and LANDesk systems in a multi protocol environment. May create design changes when necessary. Provides performance statistics and reports as needed.
- Exercises independent judgment within scope of authority. When necessary, escalates issues to supervisor to determine appropriate authority level to ensure prompt and appropriate resolution within the context of organizational priorities.
- Develops and executes data backup procedures and disaster recovery strategies, ensuring the network integrity and security at all times. Ensures timely patch management and antivirus protection.
- Leads systems integration projects to successful completion.
- Collaborates with quality and regulatory groups to manage and prioritize testing, qualifications, and validations to ensure consistent functionality and cGxP compliance.
- Leads in the design of user access rights for all networked systems. Reviews and approves user access rights creations and modifications. Ensures overall network security, proper documentation and compliance with cGxP and 21 CFR part 11.
- Develops infrastructure improvement plans and directs the procurement of hardware and software in a cGxP environment.
- Ensures network support for MBL's telecommunications infrastructure including, but not limited to, telephones, VOIP, videoconferencing, and wireless and wired network line requests.
- Proposes IS solutions based on SME documented user needs. Obtains ratification to prioritize and implement IS solutions. Performs network improvements, upgrades and repairs as necessary.
- Provides timely and appropriate network support and training to helpdesk staff and end users.
- Performs risk and vulnerability assessments, including network or system audits. Leads the development of plans to anticipate and prevent potential network or system failures and ensures the resolution of any network or system failures that arise.
- Documents all work according to MBL-IT standards and cGxP. Writes and edits cGxP documentation including but not limited to SOPs and change controls.
- Ensures that all aspects of networks and systems adhere to MBL-IS standards, cGxP, and other applicable regulations. Including but not limited to 21 CFR part 11.
- Maintains up to date knowledge of industry trends and best practices.
- Maintains effective communication and relationships internally and externally to MBL.
- Performs additional job related duties as required.
- Bachelor’s degree in Computer Science or related field with a minimum 5 years of relevant experience or equivalent combination of education and experience
- Ability to follow instructions precisely , recognize deviations, and recommend corrective action
- Prior experience in a cGxP regulated environment is preferred. Strong working knowledge of cGxP, 21 CFR part 11, and MA data security regulations preferred
- Demonstrated ability to train others
- Ability to conduct complex troubleshooting
- Demonstrated proficiency in current and MBL owned versions of MS Active Directory, Exchange and Windows operating systems required with additional experience working with any of the following preferred: VMware ESX and vSphere, EMC SAN, NetApp NAS and SharePoint
- Occasional travel may be required
- Ability to work flexible and, at times extended hours to meet business needs to support a 24 / 7 / 365 manufacturing operation
- Ability to routinely lift up to 50 lbs using proper lifting technique (monitors, servers, switches)
- Strong critical thinking, time management and organizational skills. Demonstrated ability to multitask and consistently meet deadlines
- Possesses well developed attention to detail, ability to maintain accurate records and excellent proofreading skills
- Excellent written and verbal communication skills. Ability to communicate effectively (up, down, and laterally) with others
- Demonstrated initiative through past experience
- Ability to work effectively both independently and as a member of a team