Job Title: IT Specialist III, GMP Systems
Department: Information Systems
Location: Redmond, WA
Reports to: Senior IT End User Services Manager
The Role: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.
What You'll Do:- 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.
Who You Are:- 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.
Why Join Us:- Growth Opportunities: We're a company that believes in continuous learning and development. Whether it's professional courses, mentorship, or new projects, we'll help you grow.
- Inclusive Culture: We're committed to building a diverse and inclusive environment where everyone's voice is valued, and curiosity is encouraged.
- Innovative Projects: You'll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.
- A Place for Big Ideas: We don't just talk about thinking outside the box-we throw the box away. If you've got ideas, we want to hear them.
The base pay range for this position at commencement of employment is expected to be $115,000 to $126,500; Base salary offered may vary depending on individual's skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.
