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Sr. It Associate Jobs

Company

Summit Biosciences Inc.

Address Lexington, KY, United States
Employment type FULL_TIME
Salary
Category Pharmaceutical Manufacturing
Expires 2023-08-13
Posted at 9 months ago
Job Description
The Senior IT Associate will be responsible for various aspects of the start-up, operation, maintenance and hands-on administration of plant information systems. The position will also lead or assist in the installation, maintenance, upgrade and support of all company servers, website, specialty computer systems and network security.


The Senior IT Associate is responsible for leading projects to upgrade or troubleshoot computer related systems, source and implement new equipment, assist in validation activities for computerized systems, increase efficiencies, and serve as a technical expert on information technology related issues.


Company Benefits:


  • Short/Long Term-Disability
  • PTO
  • 401k Plan
  • Vision
  • Growing Organization
  • Paid Holidays
  • Health
  • Life Insurance
  • Dental
  • Team-Oriented Environment


Essential Duties:


  • Design, install and upgrade network security devices to provide protection from current outside threats, such as virus, trojans, hackers, etc.
  • Assist with troubleshooting and repair of information management systems and equipment.
  • Provide day to day support for all information management systems.
  • Lead projects such as; new equipment design and procurement, technology transfer, and process optimization.
  • Install hardware, software and other technology.
  • Provide technical input to equipment design and upgrades.
  • Work on computerized systems acceptance, installation, startup, optimization and validation activities.
  • Backup of information management systems per company procedure.
  • Design, install and upgrade information systems to meet company needs.
  • Other duties as assigned.
  • Develop validation documentation with minimal oversight for computerized systems in alignment with approve validation plan. Written validation documents include: IQ/OQ/PQ, User Requirements, Design Specifications, and Test Scripts.
  • Manage and maintain building access control systems, security system and video surveillance system.
  • Develop and maintain detailed action plans and project plans for major computerized systems implementation.
  • Write and revise SOPs and Forms to maintain up to date and accurately reflect the current procedures for information management systems.


Minimum Qualifications:


  • Must be flexible, adaptable, self-motivated and able to work well independently and across teams and partners.
  • Motivated self-starter with excellent organizational skills and attention to detail.
  • Ability to work in a lean, action oriented organization and demonstrate a strong work ethic.
  • Good written communication skills to read and write SOPs and complete documents.
  • Motivated to perform work while maintaining a focus on the long-term, continuous improvement of equipment, utility, and facility operation and the programs that support manufacturing.
  • Strong interpersonal and communication skills and demonstrated ability to effectively communicate with all departments including coordination of activities with manufacturing and laboratory personnel.


Qualifications:


  • Experience with SQL and Oracle.
  • BS in Computer Science, Information Systems or related field, or equivalent working experience.
  • 2-3 years of FDA regulated cGMP environment validation experience.
  • Good interpersonal skills and the ability to work well in a team environment.
  • Experience with Linux.
  • Ability to work with cross functional teams and meet performance requirements.
  • 5-7 years of hands-on experience, preferably in a FDA regulated cGMP environment.
  • CCNA, MCSA, or MCSE Certification.
  • Self-starting and multitasking.
  • Extremely detail oriented.
  • Qualified to work with controlled substances.
  • Excellent technical writing and organizational skills.