What are the responsibilities and job description for the IT Lab Manager position at EyePoint Pharmaceuticals, Inc.?
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
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, we are seeking a highly motivated individual to provide on-site technical support and manage IT systems in our GmP 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 support for all things IT in the facility, in addition, the Manager 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.
This person will report to the VP, IT. We offer a hybrid work schedule.
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.
- Lead system implementations and architecture design for laboratory equipment, ensuring seamless integration with IT infrastructure and alignment with regulatory standards.
- Support and perform system 21 CFR Part 11 and Risk assessments, periodic reviews, and maintain support-related logbooks and documentation.
- Conduct 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 and AWS.
- Manage 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:
- Coordinate change controls for planned system changes, ensuring that all changes follow the necessary approval processes and comply with regulatory requirements.
- Ensure that all laboratory 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.
Qualifications:
Level of Education Required:
Preferred Field of Study:
Computer Science, Information Science, or related fields.
Number of Years of Experience in the Function and in the Industry:
6-8 years of experience in FDA-regulated environment and associated GxP controls for software development
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.
Transformational Innovation
We exist to change our patients’ lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology.
Unwavering Integrity
We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us.
Compassionate Excellence
We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes.
Inclusive Collaboration
We strive to see through the eyes of others and work as one team. We appreciate one another’s differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward.
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.
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