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Summit Biosciences is a specialized pharmaceutical company that develops, manufactures, and commercializes prescription nasal spray products. Summit Biosciences is experiencing significant growth and offers competitive compensation + annual bonus, 401k plan, paid holidays, PTO, health/dental/vision/life insurance, short/long term-disability, an incredible collaborative and challenging culture in a team-oriented environment.

Summit Biosciences is an Equal Opportunity Employer. Summit Biosciences does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by applicable federal, state and local laws. All employment is decided on the basis of qualifications, merit, and business need.

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.

Essential Duties:

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

Minimum Qualifications:

• Motivated self-starter with excellent organizational skills and attention to detail.
• Strong interpersonal and communication skills and demonstrated ability to effectively communicate with all departments including coordination of activities with manufacturing and laboratory personnel.
• 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.
• Must be flexible, adaptable, self-motivated and able to work well independently and across teams and partners.
• 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.

Qualifications:

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