Job Title: Equipment Validation Engineer
Location: Boston, MA
Duration: 12 Months
Job Description:
We are seeking an Equipment Validation Engineer III and IV to ensure all critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters, and global regulatory guidelines. This role provides Operations, Quality Assurance, and regulatory bodies with scientifically sound, documented evidence that systems and processes will perform as required, ensuring a quality, compliant manufacturing environment.
Key Accountabilities:
- Provide SME support for the design, operation, and troubleshooting of equipment.
- Drive and execute validation plans for equipment changes and process improvements.
- Execute Installation Qualifications/Operational Qualifications and draft Performance Qualifications.
- Perform Equipment Validation activities, including Validation Maintenance Quality Systems review and requalification.
- Program, organize, and maintain validation equipment and supplies.
- Develop validation protocols from plans and engineering documents.
- Provide technical support for SOPs, Protocols, Change Controls, Deviations, CAPA, etc.
- Perform Quality Systems activities within DMS, LIMS, and TrackWise Quality System.
Skills:
- Advanced technical knowledge of Quality Control and manufacturing operations.
- Experience with Quality Systems including deviations, change controls, CAPAs, and OTNs.
- Knowledgeable in process, equipment, cleaning, and computer system validations.
- Ability to manage medium to large-sized projects within required timeframes.
- Effective planning, organizing, and controlling skills.
