Quality Engineer I

Ology Bioservices, Inc.
Job Description
DESCRIPTION

Responsibilities include:

 

  • Support CQV Commissioning, Qualification and Validation effort for Facilities, Utilities, Systems and Equipment in biotechnology facilities.

  • Review, Approve, and Maintain documentation such as SOPs, specifications, protocols, and reports for CQV activities.

  • Maintain the validated state where applicable.

  • Follow applicable standard operating procedures while working in validated systems.

  • Generate field and technical reports as needed. Analyze data from Facilities, Utilities, Systems, Equipment from all areas with emphasis on the Mfg. runs for troubleshooting equipment systems with a cross functional team of Mfg., Facilities and Quality.

  • Use theoretical and applied knowledge of utilities, instrumentation, validation and GMP regulations applicable to automated facilities and utility systems.

  • Support root cause investigations and corrective actions.

  • Ability to manage multiple priorities.

  • Other responsibilities, as required by management such as procurement support, mentoring, leadership, and contractor oversight.

  • Motivated, self-starter, excellent problem solver, outstanding communication skills.

  • Full time position, which may include after hours and weekend effort as needed.

POSITION REQUIREMENTS
  • BS degree required; preferably in a technical field.

  • 5+ years of hands-on experience Quality Systems.

  • Comprehensive understanding of qualification or validation protocols, with ability to develop new more robust risk based qualification approaches for risk reduction.

  • Proficiency with Microsoft Office Suite.

  • Familiarity with regulated industries such as biotechnology, medical device or pharmaceutical manufacturing required.

  • Strong initiative and integrity as well as strong written and verbal communication skills.

  • Proven ability to successfully work independently and within teams.

Must be able to support shift operations at the facility.

NUMBER OF OPENINGS 1  
EOE STATEMENT Ology Bioservices,is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national origin, gender,sexual orientation, gender identity, age, physical or mental disability, genetic factors, or military/veteran status or any other characteristics protected by law.

EEO Minorities/Women/Disabled/Veterans  
ABOUT THE ORGANIZATION Thank you for your interest in joining the Ology Bioservices team! We believe we have the most talented and committed employees in the industry with decades of combined experience in manufacturing, developing and licensing vaccines and protein/antibody therapeutics.
Ology Bioservices is a full-service Contract Development Manufacturing Organization specializing in biologic drug substance manufacturing from early stage through commercial product. The company has 183,000 square feet of manufacturing, process development and QA/QC space in our state of the art Advanced Development and Manufacturing ADM) facility in Florida. Ology Bio has 20 years of experience developing and manufacturing drugs and biologics for the US Government, and over $500M in government contracts awarded over that time.
The company expanded to Commercial Manufacturing upon the move into the new facility in early 2017. Our infrastructure provides unique services to our clients, including full regulatory support from preclinical through licensure, clinical trial operational support and bioanalytical testing, as well as cGMP manufacturing up to Biosafety Level 3 (BSL3).
We offer outstanding career growth opportunities, excellent fringe benefits, and competitive pay.
We are an Equal opportunity Employer
AA/EEO Minorities/Women/Disabled/Veterans  
POSITION Quality Engineer  
LOCATION Alachua  
Contact Information