Just-Evotec Biologics is seeking a highly motivated and creative IT Specialist to join a fast-paced, collaborative, and multidisciplinary team to provide support with manufacturing systems. The ideal candidate will have experience implementing and supporting GMP manufacturing systems within the Biotech/Pharma industry.Responsibilities:
Qualifications and Education Requirements:
- Follow Computerized Systems Validation (CSV) process and Software Development LifeCycle (SDLC) methodology to build out and qualify/validate systems.
- As application SME, work with infrastructure teams to implement and support systems such as DCS/PAS/MES.
- 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.
- Work with infrastructure teams to assure proper backups systems are setup.
- Use various IT tools such as windows NTFS permissions, active directory, group policies, etc. to implement and deploy systems with data integrity risks minimized.
- Deploy workstations and install applications on both client and servers as needed.
- Contacting vendors as needed for troubleshooting and resolving issues.
- Creation of user accounts in applications as needed following administration procedures.
- Bachelor's Degree or technical institute degree in Computer Science, Information Systems, or other related field; or equivalent work experience
- 3+ years of experiencing working within the Biotech or Pharma industry supporting critical Manufacturing Systems.
About Just - Evotec Biologics
- Strong understanding of regulatory requirements (21 CFR Part 11, Annex 11) as they pertain to computerized systems.
- Familiarity with performing Data Integrity assessments and remediations for Laboratory computer systems.
- Experience developing processes, Standard Operating Procedures (SOPs), and data storage requirements to ensure compliance with regulatory guidelines.
- Familiarity with control systems such as; DeltaV, SCADA systems, Building Automation systems is preferred.
Just - Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just's focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle's South Lake Union neighborhood - the center of Seattle's medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 100 employees is expanding Just's innovative platform and footprint - building our first North American J.PODÂ® commercial manufacturing facility in the Seattle area. For job opportunities, learn more at www.just.bio/careers