IT Systems Analyst, GMP Systems
Company: Evotec WD
Posted on: May 19, 2023
IT Systems Analyst, GMP Systems page is loaded IT Systems
Analyst, GMP Systems Apply locations Redmond Seattle time type Full
time posted on Posted Yesterday job requisition id JOB ID-08068 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
- Lead or coordinate technical discussions and vendor
- 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
- 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. About Us Evotec is a life science company with a unique
business model focused on delivering highly effective new
therapeutics to the patients. The Company leverages its
multimodality platform, the "Data-driven R&D Autobahn to
Cures", for proprietary projects and within a network of partners
including Pharma, Biotech, academics, and other healthcare
stakeholders. With more than 4,500 highly qualified people at 17
sites, Evotec aims to create the world-leading co-owned pipeline
for innovative therapeutics. For additional information please go
to www.evotec.com and follow us on Twitter @Evotec and LinkedIn .
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Keywords: Evotec WD, Redmond , IT Systems Analyst, GMP Systems, Professions , Redmond, Washington
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