Validation Engineer, Biotech
Sanaria is a biotechnology company developing a live sporozoite malaria vaccine. The company is moving into Phase III clinical trials. We have an opening in our Quality and Operations Departments for a Validation Engineer.
The Validation Engineer will evaluate and calibrate the equipment and procedures used in development and production of Sanaria vaccine products. The VE will ensure all systems are running according to necessary specifications and operate within regulations to ensure the production of quality cGMP products.
Validation responsibilities include equipment budgeting, purchasing, monitoring and testing. The successful candidate will be familiar with industry standards and regulatory guidelines and also oversee the work of validation personnel and contractors.
The primary duty of the Validation Engineer is testing. The Validation Engineer will establish validation standards, develop testing protocols, prepare equipment, document test results and maintain records for later analysis. S/he will often need to coordinate with other personnel or departments who will be affected by testing.
The Validation Engineer will write reports and make adjustments to equipment or processes that require improvement. S/he will assess and help decide if equipment needs to be repaired or entirely replaced. Other duties include preventative maintenance, maintenance of testing equipment and overseeing the inventory of validation supplies.
- Bachelors degree in a science or engineering related field.
- 3-5+ years of validation experience or related QC, Micro, Manufacturing experience in a cGMP environment.
- Experience working with analytical and statistical tools.
- Clean room experience is required including validation of utilities in a clean room manufacturing facility.
- Work experience in a cGMP manufacturing facility and working knowledge of related industry guidance and regulations pertaining to validation.
- Experience performing (writing and executing) IQ/OQ/PQs for manufacturing and laboratory equipment.
- Experience with temperature mapping using Kaye Validator, Val Probes, Veriteq dataloggers.
- Strong technical and problem solving skills. A statistical background is preferred.
- Excellent interpersonal, written and oral communication skills.
- Must be able to demonstrate a professional attitude in dealing with other departments in the organization, vendors, and contractors.
- Must be able to work well with a team or individually to successfully complete validation projects.
- Must be able to set priorities among multiple tasks.
- Proficient in Microsoft Word, Excel, Power Point and Project.