Quality Engineer

Job Locations US-MA-Bedford
Posted Date 1 month ago(7/20/2022 11:40 AM)
Job ID
# of Openings


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 project team, 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 conduct 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 on electronic asset manager.
  • Review & assess out of tolerance notifications and unscheduled maintenance work 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.
  • 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


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