Digital Assurance Engineer
Resilience is ushering in an era of 'Bio manufacturing-as-a-Service' that we expect will displace in-house manufacturing as well as traditional contract manufacturing and development organizations (CDMOs). We see this as a paradigm shift in biomanufacturing akin to the IT industry's adoption of Infrastructure-as-a-Service (IaaS) and Platform-as-a-Service (PaaS) that rendered obsolete corporate-owned/operated data centers or corporate servers co-located in hosting facilities.
The Digital Assurance Engineer will be responsible for oversight of all GxP-Regulated software and computerized systems at all applicable points of the software lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV), Computer System Assurance (CSA), and Lifecycle procedures with Data Integrity requirements. This individual will provide oversight of validation activities, develop and approve validation documentation, risk assessments, work with project teams to determine which elements should be validated, and conduct impact assessments of proposed changes to software solutions and computerized systems. The incumbent will provide the necessary oversight of software related issues, employ risk-based methodology, and ensure that all GxP computerized systems are maintained in a validated state throughout their lifecycle. Additionally, the individual will focus on ensuring consistent policy administration, implementing key improvement initiatives and solving compliance issues.
Experience, Skills, and Abilities
|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.
|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
|POSITION||Digital Assurance Engineer|