Senior Validation Engineer, Pharma Process Validation

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. 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