Validation Engineer III

Ocular Therapeutix, Inc.; Bedford (MA); On-site; USD 135,000 - 140,000; Full time

Job summary

Ocular Therapeutix, Inc. is seeking a seasoned validation scientist to design and execute protocols for equipment and processes meeting strict purity, safety, and quality standards.

You will analyze data, develop validation plans, and prepare technical reports across multiple product platforms. The role requires a Master’s degree in Chemistry or Pharmaceutical Science with 5+ years in pharma/medical device process development, deep cGMP knowledge, and experience with IQ/OQ/PQ/RQ and cleaning

Qualifications

• Master’s degree in Chemistry, Pharmaceutical Science, or a related field with 5+ years in pharma/medical device process development.

Responsibilities

• Design and plan protocols for equipment or processes to meet purity, safety, and quality requirements.
• Study product characteristics and customer requirements to determine validation objectives and standards.
• Analyze validation test data to determine if systems or processes meet criteria and identify root causes of issues.
• Develop validation master plans, process flow diagrams, test cases, and SOPs.
• Prepare detailed reports and design statements from validation results and protocol reviews.
• Maintain validation test equipment and review technical documents.
• Document technical design details and maintain test equipment.
• Support validation activities for cleaning, product, equipment, utility, and facility systems including chemical analysis of residues and degradation products.
• Ensure cleaning validation is maintained for commercial products and products in clinical development across multiple platforms.
• Responsible for Continued Process Verification, authoring technical reports, and developing cleaning validation procedures and analytical methods.

Skills

Process validation

cGMP knowledge

IQ/OQ/PQ/RQ protocols

FDA/regulatory compliance

Validation risk assessment

Education

Master’s degree in Chemistry/Pharmaceutical Science or related field

Tools

21 CFR Part 11

Lyophilization

Extrusion

Injection molding

Job description

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.

Principal Duties And Responsibilities Include The Following

• 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.

Qualification Requirements

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

Salary Range: $135,000 USD – $140,000 USD

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 CCAA Applicant Notice.