Vacancy expired!
working on site 60% of the time during COVID-19
The Validation Engineer will provide technical support in all validation activities in alignment with client Commissioning and Qualification Process (CQP) to ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices. Also support the commissioning strategy based on the URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES) to validate equipment design while minimizing project cost and schedule impact (risk-based approach). The Engineer will review User Requirements Specifications (URS) and work in partnership with the Maintenance, Project Management, Engineering Technical Lead, and Manufacturing to develop and oversee the operation and reliability of equipment. In addition will work closely with Quality Assurance (QA) for GMP compliance and provide broad operational support to the manufacturing floor scientific, technical interactions with partner organizations such as Process Development (PD) and Clinical Process Engineering (CPE). Development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and cGMP standards. Review the commissioning reports and ensure that all verification exceptions have been adequately addressed. Ensure safety during commissioning, validation, maintenance and manufacturing activities. Collaborates with Regulatory and Quality partners to assess change control records and respond to regulatory questions and/or findings. Serves as technical expert to lead or participate in projects to introduce new products and/or advanced technologies into the plant. In addition, the Validation Engineer will support periodic review of manufacturing systems to ensure that they remain in a validated state. The Engineer will support the projects in defining strategies for quality systems verification and work with the process development team to develop and document appropriate practices for characterization. The validation engineer is a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making. Relies on instructions and pre-established guidelines to perform the functions of the job. Works under immediate supervision. Typically reports to a supervisor or manager.
Education Requirement - Bachelors with degree in engineering, chemical engineering preferred.
Education Requirement -
Bachelors with degree in engineering, chemical engineering preferred.
Top 3 Must Have Skill Sets:
1. General knowledge on Biopharmaceutical equipment operations and processes such as single use technologies, Media / Buffer Prep solutions, Inoculation, Bioreactors, Harvest, Chromatography and Tangential Flow Filtration as well as Clean Utilities (intermediate level)
2. General equipment knowledge to perform basic troubleshooting of equipment failures or malfunctions and/or the development of technical assessments. (intermediate level)
3. Experience in validation processes such as execution of Installation / Operation / Performance qualification documentation. (expert level)
