IT Specialist III, GMP Systems

Evotec•Redmond, WA

1d•Onsite

About The Position

We’re looking for a passionate and curious IT Specialist III, GMP Systems to join our team. If you’re excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you’ll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories. As a IT Specialist III at Just-Evotec, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s a role where your curiosity will fuel both your personal growth and the success of the team.

Requirements

Bachelor’s Degree or technical institute degree in Computer Science, Information Systems, or science related field; or equivalent work experience.
5+ years of experience working within the Biotech or Pharma industry supporting critical Manufacturing Systems.
Biopharmaceutical or similar Manufacturing domain.
Experience as a System Owner for validated GxP Systems.
Familiar with Data Integrity methodologies.
Experience writing Standard Operating Procedures (SOPs).
Basic knowledge of Manufacturing Execution Systems, Distributed Control Systems (DeltaV), LIMS, Data Historian, ERP etc.
Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21 CFR Part 11,cGMP Annex 11, Data Integrity principles.

Responsibilities

Directly responsible for the deployment, support, and troubleshooting of end user devices such as laptops, workstations, printers, tablets, phones, and audio/video services.
Directly responsible for the configuration, deployment, and support of GMP systems in a manufacturing facility or laboratory environment
Take over the responsibility as a System Owner for Manufacturing IT Applications and/or QC Analytics systems in a 24x7 Good Manufacturing Practice (GMP) environment.
Work with the Business Process Owners for the upgrade/patching and changes to the system to ensure GMP compliance.
Follow Computerized Systems Validation (CSV) process to build out and qualify/validate GxP systems.
Directly responsible for deployment, as well as authoring IT validation documents such as System Design and Configuration Specifications (SDCS’s) and Installation Qualifications (IQ), Backup Configuration and Restore Protocols, and System Administration Procedures.
Assist with and provide input as SME and System Owner for other documents in validation process, such as User and/or Functional Requirements, Risk Assessments, Operational Qualification related to software functions, etc.
Familiar with Quality Change Management software/processes, to document activities during the project and provide impact assessments.
Experience implementing various IT tools such as windows NTFS permissions, active directory, group policies, etc. to configure systems to meet data integrity and regulatory requirements.
Contacting vendors as needed for troubleshooting and resolving issues.
Creation of user accounts in applications as needed following administration procedures.