Equipment Manager, Quality Technology Systems & Solutions

Ocular Therapeutix•Bedford, MA

9h•$125,000 - $158,000•Onsite

About The Position

Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space. Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity. Position Summary: The Quality Technology Systems and Solutions (QTSS) Equipment Manager is responsible for the following: QC Equipment and related software implementation Overseeing routine Maintenance, Calibration and Qualification of pre-existing QC systems Acts as a back up for Administration of Quality Control Software Systems, including but not limited to Empower, Tiamo, OMNIC, ECLIPSE, DataPro2, etc. Troubleshooting and triaging QC Instrumentation/Software issues This position is onsite and reports directly to the Sr. Manager, QTSS

Requirements

Degree in a scientific field preferred
5-10 to years of experience in an Analytical or QC Laboratory or with Equipment Implementation in a GMP setting
Knowledge of Computer System Validation and 21 CFR Part 11 compliance requirements.
Experience with analytical test equipment software validation and administration
Knowledge of applicable USP, ICH, EP guidelines relating to QC Equipment
Waters Empower experience, with laboratory experience desired
Must have good communication and organizational skills
Experience with LC, GC, KF, Endotoxin, EM Equipment experience required

Responsibilities

This role oversees all QC Equipment across multiple QC departments to ensure compliance with GMPs and ISO guidelines, includes: o Routine maintenance and qualification of systems o Maintenance of service contracts with equipment suppliers
Equipment Implementation for QC systems including: o Authorship of Administration and Usage SOP’s o Reads user manuals and determines how to configure software systems associated with equipment to meet business needs
Works with business owners to justify and procure new capital equipment for the QC departments
Coordinates with external groups including calibrations, validation, facilities, IT, QA and equipment vendors to bring in and set up new equipment
This role provides back up support to the system administrators and assists with maintenance of routine operation of the analytical instrument data systems, managing system access, ensuring high quality and timely system output, and all end user requests, including troubleshooting
Troubleshoots and triages QC Equipment and related software issues as they arise
Manages Change Controls and other Quality Events related to QC Equipment and related software systems
Supports GMP IT updates related to QC systems, as required
Builds and maintains strong relationships and collaborates closely with other departments which interface with Quality Systems, including QC Raw Mats, QC Commercial, QC analytical, QC Stability and QC Micro, IT, Validations, etc.
Future potential for growing a team of technicians to help provide support to the equipment aspect of the QTSS department