Validation Engineer III

Ocular Therapeutix•Bedford, MA

1d•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™. The company has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and aims to become a leader in the ophthalmic space. Outside of the ophthalmic realm and behind the doors of their headquarters in Bedford, MA, Ocular Therapeutix strives to build a strong culture where employees can flourish and achieve their career goals, encouraging out of the box thinking, cross-functional collaboration, and creativity.

Requirements

Master’s degree in Chemistry, Pharmaceutical Science, or a related field
Five (5) years of experience in pharmaceutical/medical device process development.
Five (5) years of experience with current Good Manufacturing Practices (cGMP) for commercial and clinical batch manufacturing of drug/drug-device products.
Five (5) years of experience applying 21 CFR Part 11 regulations and EU regulation (Annex 1 and 11).
Five (5) years of experience with IQ, OQ, PQ, and RQ protocol authoring, execution and reviewing for manufacturing, facilities, quality control, process, and computer system validation.
Three (3) years of experience performing validation risk assessments related to FMEA, change controls, deviations, and CAPAs.
Two (2) years of experience with cleaning validation, including cleaning risk evaluation, swab/rinse sampling techniques, and swab/rinse sample analysis.
Two (2) years of experience with lyophilization, extrusion techniques and injection molding.

Responsibilities

Design and plan protocols for equipment or processes to produce products meeting internal and external purity, safety, and quality requirements.
Study product characteristics and customer requirements to determine validation objectives and standards.
Analyze validation test data to determine whether systems or processes have met validation criteria and identify root causes of production problems.
Develop validation master plans, process flow diagrams, test cases, and standard operating procedures.
Prepare detailed reports and design statements based on validation and qualification test results and reviews of procedures and protocols.
Maintain validation test equipment, review technical documents, and prepare detailed work plans.
Document technical design details and maintain test equipment.
Support validation activities associated with cleaning, product, equipment, utility, and facility systems, including chemical analysis of cleaning agent residues, drug substances, and degradation products.
Ensure cleaning validation is conducted and maintained in a state of validation for commercial products and products in process of clinical development and commercialization across multiple therapeutic chemical drug substance platforms.
Responsible for Continued Process Verification, authoring technical reports, and developing new cleaning validation procedures and analytical methods.