Careers

Position Description: Manufacturing Support Engineer

Job Title: Manufacturing Support Engineer
Location: La Jolla, CA
Department: Product Development / Manufacturing
Reports To: Product Development Manager

Summary

Responsible for a diverse set of process and product development and improvement functions related to new and existing products. Designs and executes experimental studies and engages in prototyping and scale-up activities. This individual performs fundamental engineering and design functions such as calculations, equipment and materials selection and preparation of specifications. Understands and employs scientific and engineering practices according to the individuals discipline. Provides technical input to internal customers on issues of manufacturing changes, test methods, validation, and regulatory compliance.

This individual is responsible for performing overall process or product design and development functions including concept, feasibility and detailed engineering, as related to individual disciplines. This position applies sound knowledge of process and/or product design principles to affect the engineering, procurement and manufacturing start up for new products and processes or improvements to existing products and processes. This position may be globally responsible for project-wide process or product engineering. This position is well adapted to working independently with minimal direction.

This individual may be responsible for project creation and execution including program budgeting and scheduling and for assuring that process or product requirements are met.

ESSENTIAL DUTIES AND RESPONSIBILITIES
The duties and responsibilities of this position include the following, although other duties may be assigned.

Experimental Design/Prototyping

Designs, writes, and executes tests and protocols. Thoroughly reviews literature, industry intelligence, and previous experimental reports. Designs, builds, and refines prototypes. Develops parameters for equipment and process validation.

Project Design/Management

Performs detailed designs of the project from concept and layout through development and qualification. Plans and communicates the status, requirements, investigative findings, and decision points of current projects.

Documentation

Creates documentation to support the various development activities as part of the Quality System, including CARs/CCB/MRB/OOT, qualifications, and validations. Generates reports on testing activities and prepares standard operating procedures.

Sourcing

Searches out appropriate vendors, materials, and components to complete projects.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The requirements described above will be highly dependent on department needs. However, this position may require any/all of the following:

Experience in a cGMP environment. Including clean rooms and laboratories.

Experience and/or training in biology, statistics, materials science or classical engineering training specific to FDA regulated industries.

Knowledge of experimental design, instrumentation, and data collection.

Ability to summarize and present scientific information, requiring both oral and written communication skills.

Technical knowledge of bioreactor design, fluid mechanics, and solid mechanics.

Understanding of computerized documentation methods, CAD, LEMS, etc.

Machine shop exposure

Ability to work with and mentor others in a team environment

Education and/or Experience

BS degree in chemical engineering, bioengineering, mechanical engineering, materials science, or related discipline, with 1 or more years of professional experience, a minimum of 2 years preferred.

Language Skills

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedural manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, vendors and the general public.

Mathematical Skills

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

Reasoning Ability

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

CERTIFICATES, LICENSES, REGISTRATIONS

None required.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Routine laboratory bench work may be required (including standing and light lifting) as well as the ability to work in a clean room environment (gowning required) and the ability to use appropriate personal safety equipment.

We are an Equal Opportunity Employer.

LOCAL CANDIDATES ONLY