Digital Assurance Engineer

Ology Bioservices, Inc.
Job Description
DESCRIPTION

Role

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.

Responsibilities:

  • Review all computer systems validation documentation and resolve gaps with cross-functional teams to produce final documentation to Digital department management for approval.
  • Serve as the Digital Department liaison for computer systems validation documentation.
  • Perform and/or direct GxP computerized system validation projects in compliance with cGMP, 21 CFR Part 11, Annex 11 and Data Integrity.
  • Ensure that GxP systems meet intended use and comply with applicable regulations, current industry practices, and Ology Bioservices policies and procedures. Validation projects may include manufacturing systems, lab systems, facilities systems and steady state activities around these applications.
  • Plan and establish document flow, testing requirements, and resources necessary to complete the validation of a system.
  • Assure compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements as related to validation.
  • Assist in development of Validation life cycle documentation such as Systems Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Design Qualification (DQ) Validation Summary Reports, and Deviations reports for software and computerized systems.
  • Analyze and interpret validation test data to determine whether systems or processes have met validation criteria or to identify root causes of deviations.
  • Facilitate change control requests and deviations related to IT systems.
  • Contribute to sprint activities such as retrospectives and release readiness reviews
  • Perform other duties as assigned.
POSITION REQUIREMENTS

Experience, Skills, and Abilities

  • Must have a minimum of two (2) years direct CSV validation experience.
  • Knowledge of IT Control methodologies, including GAMP5 and solid understanding of GxP guidance, including 21 CFR Part 11, Annex 11 and Data Integrity.
  • Knowledge in computerized system lifecycle activities, CSV and IT controls in a regulated environment preferred.
  • Prefer hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries.
  • Experience with and knowledge of related quality systems such as Change Control; CAPA (including: Deviations/OOSs); Training; and Document Control is required.
  • Knowledge of global regulations (e.g., FDA 21 CFR Part 11, Annex 11 etc.) and guidelines (e.g. FDA, MHRA Data integrity guidelines, etc.) around quality systems and computer system validation in Biotech and/or Pharmaceutical industry
  • Excellent communication and listening skills
  • Ability to build and maintain strong collaborative relationships across multiple departments
  • Microsoft Office and database management skills
  • Position requires knowledge of Current Good Manufacturing Practices (cGMPs) and FDA/industry regulations.
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 Digital Assurance Engineer  
LOCATION Alachua  
Contact Information