QA Validation Engineer na Ocular Therapeutix
Ocular Therapeutix · Bedford, Estados Unidos Da América · Onsite
- Professional
- Escritório em Bedford
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 Engineer will collaborate with the Validation group, R&D, Manufacturing Science and Technology (MSAT) Analytical Method Development, Quality Control, and system/equipment owners to ensure the quality of products and compliance to internal procedures and external standards. An integral member of the clinical/commercial project teams, responsible for quality oversight and phase-appropriate cGMP guidance throughout the product lifecycle. Provides technical review of process development, validation strategy, equipment, utilities, facility design, process qualification/validation documents to support clinical and commercial manufacturing. Reviews and approves quality system procedures, engineering studies, investigations, specifications and test methods that are technical in nature.
The Quality Engineer will be responsible for ensuring various technical activities at Ocular Therapeutix comply with industry standards. This individual will be involved with site inspections and compliance decisions presented to regulatory agencies and other 3rd Party audits by the Quality Engineering organization.
The individual will need to participate in conducting risk assessments (risk analysis, FMEA, PFMEA) along with the standard review and approvals of protocols and reports dealing with technical items within the organization.
May support other elements of the quality system such as change control or deviations in relationship to technical matters.
Principal Duties and Responsibilities include the following:
- Quality Assurance (QA) representative for project team(s).
- Support cleaning validation and process / equipment validation including computerized system validation.
- Review and approve validation documentation: URS, validation plans, protocols, reports.
- Review and approve R&D, MSAT and QC documentation for product progress.
- Provide Quality Assurance (QA) review of exploratory and clinical batch records.
- Perform data integrity reviews for clinical programs.
- Investigate exceptional conditions or deviations encountered during execution of validations, projects, regulatory requirements and analytical method activities.
- Provide Quality Assurance (QA) review of procedures related to validation activities
- Review equipment lifecycle forms and associated validation/calibration requirements for accuracy and completeness.
- Review equipment/system work orders in BlueMountain electronic asset manager.
- Review & assess out of tolerance notifications and unscheduled maintenance orders for impact on product, validation, calibration.
- Perform other Quality Assurance (QA) duties as assigned.
- Assist execution of all technical activities within quality assurance responsibilities.
- Oversee technical activities within the quality systems.
- Review and approve equipment/system qualification protocols and reports.
- Review and approve Process Validation protocols and reports.
- Review and approve Cleaning Validation protocols and reports.
- Review and approve CSV protocols and reports.
- Review and approve pertinent SOPs, Forms, and assorted GMP documentation.
- Ensure programing on process and packaging equipment is accurate.
- Evaluate in-process controls (IPCs) and sampling plans for cGMP manufacturing.
- Along with Process Engineers or R&D team members, informs management of issues identified during qualification activities and recommends appropriate actions to address the issue(s).
- Collaborates with MSAT and Operations to drive continuous improvement to the site equipment and facilities qualification/validation program.
- Support Annual Product Reports and analyze data to ensure control of process.
Qualification Requirements:
- Bachelor’s degree in relevant scientific discipline.
- Industry experience with quality systems and technical writing in pharmaceutical or biotech industry
- Previous validation experience preferred (equipment, computer system or process)
- Excellent organizational skills and attention to detail
- Good degree of knowledge in quality management systems.
- Has knowledge of GxP guidance relevant to role.
- Excellent verbal and written communication, technical writing
- Strong interpersonal skills and ability to work efficiently on a team
- Computer literacy, proficiency in MS Office, Excel, PowerPoint, etc.
- Ability to make decisions and resolve issues with minimal guidance
- Knowledge of FDA and international regulations
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.
