Lab Systems Analyst

Be Seen and Heard at EyePoint

At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we’re taking in business fuels our success for:

• preventing blindness through vision-saving medications
• delivering best-in-class proprietary pharmaceutical technologies
• transforming ocular drug delivery

We See You.

Your wellbeing

Your professional worth

Your future at EyePoint

EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There’s space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected.

This position is based in Northbridge, MA and will report to our IT Lab Manager. We are seeking a highly motivated individual to provide on-site technical support and manage IT systems in our GxP manufacturing facility. This role requires a strong understanding of 21 CFR Part 11, current data integrity standards in life sciences, Windows-based operating systems/networks, laboratory equipment and applications, IT infrastructure, and regulatory compliance.

The successful candidate will be our first line of support for all things IT in the facility, in addition, the Lab Systems Analyst will support and conduct system assessments such as 21 CFR Part 11 and Risk Assessments, perform periodic reviews, and maintain necessary documentation. The position also serves as a liaison between the laboratory site and other members of the IT department.

Primary responsibilities include, but are not limited to, the following:

Laboratory Computer Equipment and Applications Support:

• Provide technical support for laboratory instruments, PCs, servers, and associated applications, ensuring they operate efficiently and in compliance with regulations.
• Coordinate repairs and maintenance with external vendors to minimize downtime and optimize system uptime.
• Support cross functional system implementations
• Assist in large-scale validation efforts with varying business partners.
• Support and perform system 21 CFR Part 11 and Risk assessments, periodic reviews, and maintain support-related logbooks and documentation.
• Assist in conducting regular risk assessments and compliance evaluations to identify and mitigate data integrity gaps and system failures.

IT Infrastructure & Network Support:

• Demonstrate expertise in troubleshooting and supporting Windows operating systems, networks, and cloud platforms such as Azure.
• Support SQL databases and provide support for applications and services that rely on these databases.
• Provide on-site IT support for the Northbridge facility, including peripherals, laptops, and A/V equipment.
• Ensure system reliability and provide proactive maintenance of critical IT infrastructure to support laboratory operations.
• Conduct regular system maintenance activities, implement necessary changes, and ensure the overall health and availability of IT systems.
• Manage user access controls and permissions to ensure the security and integrity of IT systems and applications.
• Respond to technical inquiries and provide solutions in a timely manner to minimize disruptions to laboratory operations.
• Coordinate with vendors on application and firmware updates, ensuring that system enhancements are implemented seamlessly.
• Notify system owners or business process owners of any planned upgrades, including operating system patches and hot fixes.
• Maintain comprehensive documentation of application support and ensure that changes to systems and applications are tracked and updated in accordance with regulatory requirements.

Regulatory Compliance & Change Control:

• Ensure that all validated systems and processes adhere to relevant regulations, including 21 CFR Parts 210, 211, EU Annex 11, and other applicable guidelines.
• Collaborate with Quality and Regulatory teams to address compliance-related issues, ensuring that IT systems support laboratory processes in accordance with industry standards.

Primary skills and knowledge required include, but are not limited to the following:

Qualifications:

• Experience in regulated environment with associated GxP controls for software development.
• Experience with computerized laboratory/manufacturing equipment and associated processes.

Level of Education Required:

• Preferred Bachelor’s Degree in Computer Science, Information Science, or equivalent relevant experience.

Number of Years of Experience in the Industry:

• 4+ years of experience if the candidate does not possess a degree.
• 2+ years of experience if the candidate does possess a degree.

Envision Your Future

With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics.

The collective power of our values influences everything we do, and everything we do for you.

EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint’s compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity. 

The target salary range for this position is listed below.

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