Advanced BioHealing (ABH) is a specialty biotechnology company focused on the development and marketing of cell-based and tissue-engineered products. We are a privately held company with two approved products: Dermagraft® and TransCyte®. Our development pipeline also includes a next-generation bioengineered wound therapy for which two Investigational Device Exemption (IDE) applications have been approved by the Food and Drug Administration (FDA).
 
We currently have an opening for a Associate Validation Engineer II at our La Jolla, CA manufacturing facility.
 

 
Job Title: Validation Engineer II
 
Department: Validation
 

 

 
SUMMARY
 

 
Responsible for the calibration and validation of equipment and systems. Assists in equipment selection, and specification, as well as the selection of validation services. Responsible for all documentation pertaining to qualification and validation. Develops procedures and protocols. Also serves as information resource for Associate/Validation Engineers, contractors, vendors and internal customers.
 

 
Works on qualifying installed systems and software. Work may include complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. May determine methods and procedures on new assignments and may provide guidance to other personnel.
 

 

 
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
 

 
% of Time Job Task
 
5 Manage Validation Programs
 

 
30 Execute selected studies and protocols for equipment or systems.
 

 
35 Write selected studies, protocols, and reports for equipment and systems
 

 
20 Calibrate and setup validation equipment.
 

 
10 Keep abreast of current technology by attending professional meetings and seminars and reading technical literature.
 

 

 
SUPERVISORY RESPONSIBILITIES
 

 
May provide guidance to other validation personnel for specific projects as assigned by Manager.
 

 

 
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.
 

 
EDUCATION and/or EXPERIENCE
 

 
BS degree in a scientific Engineering/ discipline or equivalent with 4 + years related experience.
 

 
Knowledge: (Indicated special knowledge/areas of expertise required.)
 

 
• Validation Fundamentals
 
• Calibration Fundamentals
 
• Microsoft Excel
 
• Microsoft Word
 
• Current Validation Technology/Requirements
 
• Working knowledge of software validation
 
• Solid background and experience level with GMP’s
 
• Understanding and experience in Software Validation
 
• Familiar with equipment to include: Temperature freezers, boilers, airhandlers and cell mates.
 
• Familiar with document control systems preferred.
 

 
Skills/Abilities: (Includes technical, administrative and behavioral skills.)
 

 
• Good written skills required for writing protocols and standard operating procedures.
 
• Good communication skills required for interactions with internal departments and outside vendors and contractors.
 
• Analytical thinking/ Judgment
 

 
LANGUAGE SKILLS
 

 
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals in English. Ability to write routine reports and correspondence in English.
 

 
MATHEMATICAL SKILLS
 

 
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
 

 

 

 

 

 
REASONING ABILITY
 

 
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to define problems, collect data, establish facts, and draw valid conclusions
 

 

 
CERTIFICATES, LICENSES, REGISTRATIONS
 

 
None
 

 
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.
 

 
Must be able to lift 40lbs and above.
 
Must be able to gown and work in cleanrooms.
 

 

 
Please review our website at www.advancedbiohealing.com for more company information.
 
We offer a competitive benefits & compensation package!
 
All qualified resumes should be submitted directly to careers@advancedbiohealing.com
 

 
We are an Equal Opportunity Employer.