Opus Scientific is recruiting for Validation Engineers for a Long Island based, fast growing biopharmaceutical company with a market presence in 100 countries. Join this exciting organization offering competitive salaries and an excellent benefit package!
- Validation of automated systems, cleaning validation, and periodic assessment / revalidation activities
- Executes the testing of configuration changes to the Process Automation System and process recipes in the Manufacturing Execution System
- Supports validation work from change controls, shutdown/changeover activity, and revalidation programs
- Duties may include internal compliance or efficiency improvement efforts within department
- Demonstrated proficiency in oral communication and technical writing skills
- Strong experience in project management
- Develop, review and approve qualification and validation documents
- Oversee Manufacturing, Quality Control, Facilities, IT and Materials Management involving validation activities.
- Perform gap analysis on previously performed validation/qualifications, design and implement protocols to mitigate deficiencies in previous validation/qualifications when needed
- Review equipment manuals, specifications, drawings and operational documents to ensure validation and qualification protocols and standard operating procedures are in-line with manufacturer’s specifications, operational procedures, calibration requirements and required maintenance.
- Ensure change control procedures are followed, equipment and utility changes and provide adequate oversight and follow-up on validation deviations both in terms of content and CAPA.
- Write and edit validation/qualification protocols and SOPs.
- Assist with audits, explaining validation and qualification activities performed at the site.
- BS in Engineer (chemical preferred).
- Minimum of 5 years’ experience with biopharmaceutical / pharmaceutical industry in the areas of biopharmaceutical operations and cGMP
- Previous experience in one or more of the following items is preferred:
- Chamber validation (incubators, freezers, autoclaves)
- Experience with cleaning validation
- Experience with sterilization validation
- Knowledge of a system life cycle validation techniques for automation software specification and development
- Familiarity with SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory environment