Engineer II or III - Vialing Systems

The Engineer II or III position operates within VitriVax Process Development department. This position is responsible for building out VitriVaxs vialing equipment strategies for both research and clinical opportunities, with a focus on building robust systems to accommodate powder vialing. This position will collaborate with pilot plant engineers and other colleagues to test ALTA formulation and vial platform products with appropriate process, analytical controls, and compliance with regulations.  This role reports to the Vice President of CMC. This is a full-time position, located in Boulder, Colorado. This is a predominantly in-office position, however occasional remote work will be allowed. Responsibilities and Duties :       Design, install, and qualify aseptic powder vialing systems to support R&D development activities with appropriate scale capabilities to accommodate Phase I clinical manufacturing.        Design, install, and qualify aseptic liquid vialing systems to support Phase I clinical manufacturing. This activity may be outsourced to a CDMO, in which the engineer would manage the manufacturing relationship in the context of cost, timeline, and appropriate technical deliverables.         Design, identify, and install appropriate isolator and sterile containment equipment to enable the safe handling of powdered APIs. Support powder handling strategies throughout operations. Equipment design will be considered within cleanroom settings.      Execute vialing experiments to ensure appropriate product quality within filling performance and the stability of the API.      Author GMP equipment documents (design drawings and documents, qualification protocols, SOPs).       Assist with operation and qualification of process equipment in GMP setting as needed. Commissioing and Qualification will be conducted through the use of ISPE guidance in a risk-based approach.      Collaborate on troubleshooting and maintenance of process equipment and systems.  Education and Experience      BS or MS in Engineering or a related field.        Minimum three (3) years experience in a GMP environment Preferred previous pharmaceutical experience      Minimum of 4 years relevant experience for an Engineer II position, minimum 6 years relevant experience for Engineer III       Knowledge of FDA best practices related to design and implementation of electronic records (requirements, design, coding, testing, etc).       An established portfolio of completed biopharmaceutical engineering projects.       Experience in vialing / container-closure strategies desired.       Excellent communication, collaboration, and problem-solving skills.       Ability to work independently and take initiative in driving projects forward.       Proficiency in scientific writing and technical drawings. Core Skills and CompetenciesAll VitriVax employees are expected to share the following values. Integrity We are team players who say what we do and do what we say. We respect our obligations and are transparent in our communication. We present all data factually. When presented with ambiguous situations, we strive to do the right thing. Innovation We create value by developing superior products and processes. We have a curious mindset, apply an analytical approach and take calculated risks. We take on difficult problems and break barriers. Passion We are passionate about making vaccines accessible to everyone. We share our enthusiasm with purpose.  We are never satisfied with the status quo and want to make a difference. Quality We seek quality information, decisions and people. We put safety first and approach every opportunity with a right first-time mindset that is focused on the end goal. We are committed to continuous improvement and elimination of waste.  Salary and BenefitsAnnual Salary for this position ranges from the following depending on experience and alignment with current and future responsibilities :       Engineer II - $90,000 - $100,000 / year       Engineer III - $100,000 - $130,000 / year All full-time employees are eligible for the following benefits.      Stock Options      401(k) with generous Company match       Flexible work schedule      Generous Vacation and Sick Time      Health, Dental and Vision insurance      Short-Term and Long-Term Disability insurance and Voluntary AD&D Insurance      Flexible Spending Account      Pet Insurance and discount plans VitriVax, Inc., is an Equal Opportunity Employer and does not discriminate based on race, color, gender, sexual orientation, gender identity or expression, religion, disability, national origin, protected veteran status, age, or any other status protected by applicable national, federal, state, or local law. VitriVax, Inc. is an E-Verify employer.

recblid wruky7i42h0a81peaiyfvx54jktzkf

Salary : $90,000 - $100,000