Description
The Senior Aseptic Process Engineer position in the Particle Engineering department will participate in the design, installation, qualification, and operation of GMP process equipment and supporting facilities/utilities for the ALTA platform. This role interfaces with manufacturing and process development to ensure scale up equipment, processes and materials meet aseptic specifications. This role reports to the Head of Particle Engineering.
This is a full-time position, located in Boulder, Colorado. This is a predominantly in-office position, however remote work may be granted periodically depending on the nature of required tasks.
Responsibilities and Duties:
- Lead development of one or more GMP manufacturing unit operations. Unit operations include spray drying, atomic layer deposition, aseptic powder filling, and powder handling.
- Participate in design of GMP clinical manufacturing facilities: cleanrooms, HVAC, utilities, etc.
- Collaborate with technical peers at VitriVax and process & equipment partners on design elements described above.
- Oversee, and participate in, installation and qualification of clinical manufacturing equipment and facilities.
- Occasionally perform manufacturing activities. Train/lead manufacturing operators.
- Author and maintain GMP documentation: engineering design documents, SOP’s, manufacturing batch records, etc.
- Co-author GxP equipment documentation (FRS, DS, TP, IQ, OQ and PQ)
- Operate equipment in GxP setting to produce materials for GLP safety studies and aseptic GMP materials for clinical trials.
- Collaborate effectively with cross-functional teams (e.g., chemists, biologists, engineers) to translate research into commercially viable equipment and processes.
Education and Experience
- BS or greater in Chemical Engineering, Mechanical Engineering, or a related field with a minimum of 10 years’ experience, or PhD with a minimum of 5 years' experience.
- Aseptic process experience with proven involvement in specifying, designing, commissioning, installing, validating equipment and component designs.
- Intelligent and motivated individual that takes responsibility for completing engineering, maintenance, and operations tasks with focus on quality.
- Excellent interpersonal, problem-solving, and decision-making skills; provides strong critical thinking and constructive feedback.
- Ability to work independently and take initiative in driving projects forward.
- Proficiency in scientific writing and technical drawings.
- Ability and willingness to learn/use CAD software and other software tools.
- Able to lift up-to 50lb occasionally and able to work in a laboratory or cleanroom environment for extended periods.
The following is appreciated in the position:
- Specific experience in aseptic/sterile pharmaceutical manufacturing, spray drying, atomic layer deposition, or powder handling.
- Strong mechanical design aptitude, particularly relating to equipment mentioned above.
- Industrial control system design, electrical wiring, and PLC programming aptitude.
- Numerical programming experience: simulation & modeling, data science.
- Individuals who enjoy ‘hands-on’ equipment work.
Core Skills and Competencies
All 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 Benefits
Salary Range: $130,000K - $185,000K per annum DOE and alignment with current and future responsibilities.
All full-time employees are eligible for the following benefits:
- Stock Options
- 401(k) with generous Company match
- Flexible work schedule
- Generous PTO
- Health, Dental and Vision insurance
- Short Term Disability insurance and Voluntary AD&D Insurance
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., requires all staff to be vaccinated against communicable diseases as recommended by the CDC.
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