IT Systems Analyst, GMP Systems

The IT Systems Analyst, GMP Systems will be supporting GMP critical systems within the Manufacturing and/or Laboratory environments of Just Evotec Biologics manufacturing sites. The incumbent will have strong technical skills as well as experience in working within the constraints of GMP regulatory requirements.

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.
• Perform system administration, support/troubleshooting, and lifecycle management activities for supported systems.
• Work to identify opportunities to create additional value and improve business processes, compliance, and maximize the benefits of standardization of technologies and leverage across sites.
• Determine business criticality and product quality requirements, ensure appropriate service levels, Disaster Recovery procedures, governance, change management, compliance and operational support.
• Lead or coordinate technical discussions and vendor negotiations.
• Support regulatory audits as needed.

The ideal candidate:
Has business domain knowledge for the following area(s):

• 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.

Requirements:

• Bachelor’s Degree in Information Technologies, Engineering, Sciences or equivalent experiences.
• 3+ years of experience implementing and managing GxP computer systems in the manufacturing or laboratory domains.

The base pay range for this position at commencement of employment is expected to be $80,000 to $140,000; 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 and 401k company match, flexible 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.