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
Principal Duties and Responsibilities include the following:
- 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
Qualification 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
Working Conditions:
- Office and laboratory/clean room environments
- Must be capable of lifting up to 50lbs.
Ocular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Ocular Therapeutix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. For information on how Ocular Therapeutix collects, stores, and utilizes candidate information please see our privacy policy found at https://www.ocutx.com/privacy-policy/. For the Privacy Notice for California Job Applicants, please see CCPA Applicant Notice.
