: Validation Engineer (JP7690)
Thousand Oaks, CA
: 2 months with likely extensions
Job posting date
:17 September 2020
working on site 60% of the time during COVID-19
3 Key Consulting is hiring a Validation Engineer for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Top Must have Skill Sets:
- The Validation Engineer will provide technical support in all validation activities in alignment with client’s 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.
- 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).
- General equipment knowledge to perform basic troubleshooting of equipment failures or malfunctions and/or the development of technical assessments. (intermediate level).
- Experience in validation processes such as execution of Installation / Operation / Performance qualification documentation. (expert level).
Employee Value Proposition:
- Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
- Assist in development and review of User Requirements Specifications (URS).
- Suggest design modifications to address risks and design in quality and safety.
- Organizes, analyses and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.
- Perform basic troubleshooting of equipment failures or malfunctions and/or the development of technical assessments.
- Recommend, evaluate, and manage performance of contract resources.
- Provide oversight for verification deliverables developed by outsourced/contract verification staff.
- Act as a liaison between Engineering and Quality Assurance during project planning, execution, and closeout.
- Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.
- Ensure safety during commissioning, validation, maintenance and manufacturing activities.
- Support Manufacturing and QA with Performance Qualification (PQ) activities.
Working with latest/new technologies in single use manufacturing, first of the kind technology, working with great team
: Candidates without experience.
We invite qualified candidates to send your resume to firstname.lastname@example.org. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com
. You are welcome to also share this posting with anyone you think might be interested in applying for this role.