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3 months ago
Salary band: $10k - $15k
Location: North America, United States, California, San Diego
Job type: Permanent
Contact: PaxVax, Inc.
Category: Engineer
The Associate, Process Engineer at PaxVax will be a supporting member of the Process Development and Production team. This position will be focused on the support of both clinical and commercial production processes based in San Diego.

Essential Duties and Responsibilities:
The Associate, Process Engineer will assist in the design, implementation and sustainability of manufacturing processes from feasibility through scale-up and commercial manufacturing. Emphasis for this role focuses on ensuring robust systems using accepted GMP design controls. Candidate shall be familiar with the design qualification process, and have relevant experience to bio-processing methods. Candidate should be comfortable with good documentation practices, working within a regulated environment and making data driven decisions..3-5 years of relevant experience
.A minimum of a BS degree in chemistry, biological sciences or engineering preferred
.Experience, knowledge and ability are emphasized over specific degree
.Excellent written and interpersonal skills required
.Strong data analysis, troubleshooting and problem solving skills required

Required Skills and Knowledge:
.Working with cross-functional teams to determine system requirements and specifications
.Design and execution of controlled experiments to optimize processes, yield and/or quality
.Process development, scale-up, technology transfer and equipment/process validation activities
.Authoring of standard operating procedures, technical reports and related GMP documentation
.Understanding of practical statistics and identification of critical process parameters
.Demonstrated ability to execute medium complexity tasks and experiments independently

Desirable Skills and Knowledge:
.Equipment monitoring, maintenance and calibration
.Experience in the biotech or pharmaceutical industries
.DOE and use of statistical analysis software (JMP)
.Working knowledge of design (Solidworks) and fabrication of parts and assemblies
.Ability to read and understand drawings, schematics, tolerances and limits
.Understanding of 21 CFR parts 11, 210 and 211 a plus
.Working within a controlled production environment
.Working with potentially infectious materials

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