IT Systems Analyst GMP systems

4 weeks ago

Redmond, United States Just - Evotec Biologics Full time

Just-Evotec Biologics is seeking a highly motivated and creative IT Systems Analyst to join a fast-paced, collaborative, and multidisciplinary team to provide support with manufacturing and process development systems. The ideal candidate will have experience implementing and supporting GMP manufacturing systems within the Biotech/Pharma industry.

Responsibilities:

  • 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.
Qualifications and Education Requirements:
  • Bachelor's Degree or technical institute degree in Computer Science, Information Systems, or science related field; or equivalent work experience.
  • 3+ years of experiencing working within the Biotech or Pharma industry supporting critical Manufacturing Systems.
Preferred Qualifications:
  • 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.
  • Willing and able to travel to support Evotec sites internationally.


The base pay range for this position at commencement of employment is expected to be $100,000 to $125,350; 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.

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.

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