Validation Engineer II (Temporary/Contactor) at Inovio in San Diego, California

Job Description:

About INOVIO

INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases associated with HPV. INOVIO is the first and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to produce an efficacious, robust and tolerable immune response. Partners and collaborators include Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Defense Advanced Research Projects Agency (DARPA)/Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)/Department of Defense (DOD), HIV Vaccines Trial Network, International Vaccine Institute (IVI), Medical CBRN Defense Consortium (MCDC), National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Ology Bioservices, the Parker Institute for Cancer Immunotherapy, Plumbline Life Sciences, Regeneron, Richter-Helm BioLogics, Roche/Genentech, Thermo Fisher Scientific, University of Pennsylvania, VGXI, Walter Reed Army Institute of Research, and The Wistar Institute. For more information, visit www.inovio.com.

Job summary

The temporary Validation Engineer II is responsible for writing and executing verification and validation test protocols. Additional responsibilities include managing engineering tools by working with external vendors, performing system administration work and assisting in training new users. The Validation Engineer II is also responsible for working with project managers on outsourced sub-assemblies and helping the quality team with customer complaint investigations.

Essential job functions and duties

• Develop and execute protocols for requirement based verification testing.


• Develop and execute protocols for device validations.


• Perform system level testing on simulated and real tissue samples.


• Determine appropriate validation methodology, acceptance criteria and requirements.


• Conduct statistical analysis of test results.


• Write and release change orders.


• Administrate Inovio's traceability tool and generate the final report matrix.


• Support engineering builds and work with the engineers on design improvements.


• Provide engineering support for other departments as necessary.


• Complete other engineering duties as assigned.

Minimum requirements

• B.S. Degree in a relevant science-related field; Electrical Engineering degree preferred.


• Minimum 2 years of experience in Validation activities, including prior experience with medical devices.


• Basic knowledge of electrical circuits.


• Understanding of risk-based testing based on ISO 14971.


• Understanding of statistical analysis.


• Experience with a PLM system such as Polarion is a plus.


• Experience with product and process validation.


• Experience with FDA GMP Part 820, CE, UL and ISO 13485 preferred.


• Excellent teamwork skills required.


• Excellent written and verbal communication skills required.


• Proficient with standard Microsoft Office tools, Statistical Software, CAD.

Disclaimer

INOVIO Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, INOVIO will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, gender identity and expression, religion, marital status, registered domestic partner status, age, national origin or ancestry, military or veteran status, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

A current US work authorization is required. The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. INOVIO offers an attractive benefits package and is an equal opportunity employer.

Important notice to employment businesses/agencies

INOVIO does not accept referrals from employment agencies unless written authorization from the INOVIO Human Resources department has been provided. In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore INOVIO will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at INOVIO.