Evotec
IT Specialist III, GMP Systems
Redmond · Mid
Sponsorship not specified$115k-$127kDetected 21 days ago
SparkERPControlsGMPMentoringGxP
About 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.
- 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.
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
- 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.
- Inclusive Culture: We're committed to building a diverse and inclusive environment where everyone's voice is valued, and curiosity is encouraged.
- We can't wait to see where your curiosity leads you-and how it will shape the future of Just-Evotec.
Requirements
- Bachelor's Degree or technical institute degree in Computer Science, Information Systems, or science related field
- 5+ years of experience working within the Biotech or Pharma industry supporting critical Manufacturing Systems.
- Experience as a System Owner for validated GxP Systems.
- Experience writing Standard Operating Procedures (SOPs).
- Basic knowledge of Manufacturing Execution Systems, Distributed Control Systems (DeltaV), LIMS, Data Historian, ERP etc.
Compensation
- 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.
Benefits
- Growth Opportunities: We're a company that believes in continuous learning and development.
Company info
- 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 what's possible.
- We're on a mission to create a place where curiosity isn't just encouraged, it's celebrated.
- Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? #BeCureious with us and see where your curiosity can take you!
- In this role, you'll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories.
- It's a role where your curiosity will fuel both your personal growth and the success of the team.
- 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.
- 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.
- Biopharmaceutical or similar Manufacturing domain.
- Familiar with Data Integrity methodologies.
- Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21 CFR Part 11,cGMP Annex 11, Data Integrity principles.
- Why Join Us:
Equal opportunity
- Equal Opportunity Employer.
This listing is sourced directly from Evotec's careers page and normalized into a canonical job model.