Department: Azzur Austin, LLC
- Develop, implement and maintain equipment and systems qualification and validation protocols. Systems include:
- Analytical equipment (such as HPLCs, osmometers etc.)
- Refrigerators, Freezers, and Cold Rooms
- Execute, track and manage protocols
- Prepare and present report packages for implementation into SOP requirements
- Prepares validation master plans for facilities, equipment, and systems.
- Prepares and executes validation protocols.
- Prepares validation report packages.
- Provides expert opinion in the drafting and implementation of validation studies.
- Coordinates the timely execution of validation activities.
- Performs other duties as may be assigned.
Required Skills & Abilities:
- Experience with Thermal Data Loggers as well as pre and post calibration procedures.
- Experience with Analytical equipment validation, including HPLCs, osmometers, etc.
- Experience with data integrity related to analytical lab validation
- Working knowledge of cGMP compliance.
- Excellent written and oral communication skills.
- Knowledge of utility and process systems associated with the manufacture of a biopharmaceutical product.
- Strong working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, PowerPoint).
- Ability to work with minimal supervision.
- Working knowledge and expertise in clean room qualification.
- Working knowledge and expertise in steam sterilization processes.
- Working knowledge and expertise in computerized systems validation.
- Excellent written and oral communication skills
- Excellent organizational, analytical, data review and report writing skills
- Ability to adapt to frequent and rapid changes in the work environment and allocate, adjust and optimize time accordingly
- Ability to work independently and establish work priorities to meet targets and timelines
- Proficient in Microsoft Office
- All candidates will have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products
Working Conditions & Physical Requirements:
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. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged sitting, some bending, stooping and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- Lifting up to 25 pounds on occasion.
- Attendance is mandatory.
- Bachelor of Science preferably in Life Sciences, Chemical or Mechanical Engineering; and 5 - 7 years of experience in validation activities in facilities, commissioning, and systems qualification of which at least 1 year must be in a lead role.
- Some exposure to good documentation practices, cGMP/GLP regulations.