IT Specialist III, GMP Systems

Job Title: IT Specialist III GMP Systems

About Us:

At Just-Evotec we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team we thrive on challenging the status quo learning from each other and pushing the boundaries of whats possible. Were on a mission to create a place where curiosity isnt just encouraged its celebrated.

Are you someone who asks questions seeks answers and isnt afraid to go deeper #BeCureious with us and see where your curiosity can take you!

The Role:

Were looking for a passionate and curious IT Specialist III GMP Systems to join our team. If youre excited by new challenges solving complex problems and learning every step of the way you might just be the perfect this role youll have the opportunity to drive impactful projects collaborate with bright minds and explore uncharted territories.

As a IT Specialist III at Just-Evotec youll have the freedom to ask the hard questions think outside the box and find creative solutions that push us forward. Its a role where your curiosity will fuel both your personal growth and the success of the team.

What Youll 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 (SDCSs) 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:

• Bachelors 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 11cGMP Annex 11 Data Integrity principles.

Why Join Us:

• Growth Opportunities: Were a company that believes in continuous learning and development. Whether its professional courses mentorship or new projects well help you grow.
• Inclusive Culture: Were committed to building a diverse and inclusive environment where everyones voice is valued and curiosity is encouraged.
• Innovative Projects: Youll 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 dont just talk about thinking outside the boxwe throw the box away. If youve got ideas we want to hear them.

Are You Still Curious

If youve read this far then chances are youve got a curious mindjust like us. So what are you waiting for Take the leap and apply today. We cant wait to see where your curiosity leads youand how it will shape the future of Just-Evotec.

Let your curiosity guide your career #BeCurious and explore the endless possibilities at Evotec!

The base pay range for this position at commencement of employment is expected to be $115000 to $126500; Base salary offered may vary depending on individuals 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.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race gender age disability genetic information gender expression gender identity national origin religion sexual orientation or veteran status.