For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.
Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany. We offer a wide-range of delivery systems including prefilled-syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials, and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, at Simtra, there is a strong emphasis on quality and continuous improvement. We hold ourselves to the highest quality and regulatory standards.
While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support, and secondary packaging.
In addition to unmatched expertise and experience, we offer a uniquely collaborative approach. Clients look to Simtra as an extension of their own companies.
It is very rewarding industry to work in. Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.
Your role at Simtra BioPharma Solutions
The LIMS System Admin provides support, maintenance, and administration functions of quality computer systems such as BaxLIMS, NWA QA, Climet, Chromeleon, etc. This position works daily with Quality Control end users, Information Technology, and Validation to ensure full functionality and compliance of each QC system. This position reports to the Manager II, QC.
What you'll do:
• Perform daily monitoring checks of quality computer systems
• Initiate and complete system change controls
• Write and update quality system and end user standard operating procedures (SOPs)
• Write/perform test scripts for validated change controls
• Work with end users and IT to troubleshoot system issues
• Perform user training for quality computer systems
• Implement and validate new quality computer systems and system modules
• Creates Crystal Reports or equivalent for quality computer system data
• Patching and upgrading of quality computer systems
• Maintain full regulatory compliance of each quality system
• Owner for quality system correction action/preventative actions (CAPAs)
• Assist in coordinating project implementation efforts between IT and Quality
What you'll bring:
• Bachelor’s degree in science or computer related field required
• Minimum 3 years quality system validation and laboratory experience required
• Experience with computer system databases (SQL or Oracle preferred).
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software
(examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)
• Working experience with Crystal Reports, SQL Services Reporting Services (SSRS)/Report Application Server preferred
• Familiarity with System Design Life Cycle preferred
Physical / Safety Requirements:
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position may require sitting or standing for long hours of time.
The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.
Equal Employment Opportunity
Simtra is an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
Simtra is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.