5 month contract
Must have:
- Validation experience on the equipment side, less with computer systems (CSV)
- Strong mechanical understanding of equipment and electrical diagrams
- GDP (all writing is done by hand, not computers) and general knowledge of regulatory and compliance
Plus:
- have worked with liquid handling systems (ex. Hamilton, Beckman, Agilent)
The Validation Engineer 1- Qualification will coordinate, execute tasks, and provide technical engineering support for a variety of assets. They will primarily interact with operations, development scientists, and software engineers to ensure qualified status of our very complex operation.
Expected schedule is Monday to Friday with a first shift start time of 8am. This position may need to support weekends and holidays.
- Perform and plan qualifications and associated processes to onboard, replace, modify, upgrade, and replace assets to support the area following cGMP/GLP and Quality Management System (QMS) guidelines
- Execute and document equipment lifecycle-related activities (installations, calibration, qualifications, etc) by supporting and maintaining equipment records in our asset management and quality management systems for traceability purposes and to assure compliance with CLIA/CAP, FDA 21 CFR part 820, ISO 15189, ISO 13485, and other requirements
- Create, update, and review procedures, work instructions, guidelines, and testing documents such as installation / operational / performance qualification (IOPQ), verifications, standard operating procedures (SOP)
- Work closely with Quality and regulatory to implement and follow the required policies and procedures for asset qualification, calibration, maintenance, and software validation
- Participate of the coordination of resources to support qualifications, installations, calibrations, investigations, upgrades, and/or repairs as needed
- Support root cause investigations
- Support the creation of new training
- Support process optimization to improve efficiency and robustness
- Work together with development and software for successful technology transfer and further workflow improvements
- Support engineering operations group needs
- Participate and adhere to Company’s policies and guidelines
Qualifications:
- 1 - 3+ years of related experience with a BS/BA or higher degree in Engineering or equivalent work experience
- Good verbal and written communication skills
- Good time management skills to support a fast paced working environment
- Good troubleshooting and root cause analysis skills in both hardware and software
- Strong experience with writing and implementing test protocols and procedures
- Strong industrial electrical and mechanical knowledge
- Knowledge of IT networking and systems infrastructure
- Knowledge Safety Training, lock out tag out (LOTO), Hazardous material, and waste handling
- Hands-on experience qualifying equipment in a high throughput operation
Preferred:
- Experience executing within a computerized maintenance/calibration management system
- Experience working in a clinical laboratory-regulated environment
- Experience qualifying liquid handling equipment. (e.g., Agilent, Hamilton, Beckman, Illumina, Dynamic Devices, etc.)
- Experience with Laboratory Information Management Systems (LIMS), Manufacturing Management Systems(MES), scheduling software, Customer Relationship Management (CRM) software
- Experience working with Green Button Go (GBG)
- Experience working with Illumina NGS technology platforms
