Validation Engineer
About the job
Job Summary
The Validation Engineer is directly responsible for constructing and executing validation plans for equipment, processes and quality control. This role will include validation requirements, statistical analysis and testing protocols to ensure completed validations meet external Regulatory requirements and internal quality parameters. Additionally, this position will work closely and collaboratively with supporting functions including Development, Manufacturing and Quality. Lastly, the Validation Engineering Specialist will be directly responsible for transferring the validated process to Production, including training, process mapping, demonstration and quality requirements.
Responsibilities
- Adhere to Onkos Core Beliefs, Code of Business Conduct, all regulatory requirements, and quality standards.
- Development and execution of equipment/process validations.
- Facilitating continuous improvement initiatives.
- Supporting manufacturing and quality if work stoppages are triggered, because of a process and/or equipment failure.
- Validation transfer to production including documentation, training and demonstration.
- Root cause analysis, counter measures, and process monitoring.
- Employee training in validation, process mapping and quality controls.
- Collaboration with team members in Continuous improvements, re-validation and training.
- Other duties as assigned.
Requirements
- Outstanding communication and organizational skills.
- Bachelor’s degree in engineering, Life Sciences, or a related field.
- 5+ years of experience in validation within a regulated industry (Med Device and/or Pharma)
- Strong understanding of validation methodologies and regulatory requirements (FDA, ISO)
- Hardware/Software Validation experience
- Strong statistical skills and methodologies.
- Certification(s) in Validation and Verification is preferred.
- Must be proficient in Software validation and Electronic Data Management Software
- Must be self-motivated, able to work independently, and thrive in a fast-paced dynamic environment.
About Onkos
At Onkos Surgical, we believe individuals with cancer requiring surgery deserve solutions designed specifically for them. These individuals, their caregivers and their support network deserve an organization passionately championing their cause.
At Onkos Surgical, we exist to maintain a singular focus on surgical oncology by looking at everything we do through the lens of the cancer surgeon and their patients.
At Onkos Surgical, we will:
- Find solutions to our patients’ unmet clinical needs and advocate for their cause.
- Partner with surgical oncologists through research, education and innovation, to treat their patients more effectively and more efficiently.
- Collaborate with regulatory agencies to find pathways to provide timely solutions while upholding the highest standards of quality or compliance.
- Fulfill our employees’ desire to make a difference in the lives of the patients they serve while achieving their own professional growth.
- Deliver value to our customers and shareholders.
