Hello! Our San Diego Pharmaceutical client is actively searching for a Senior System Engineer on a contract (to hire) term.
Desired Skills & Systems Experience:
Established IT partner supporting QA, Manufacturing, and Process Development teams.
Demonstrated ability to deliver comprehensive end-user support with a high level of energy and professionalism.
Direct experience providing technical assistance for GxP‑regulated applications utilized in QA, Manufacturing, and Process Development settings. In-depth knowledge of 21 CFR Part 11, including proficiency in evaluating system changes for validation impact and facilitating revalidation activities such as IQ/OQ:
Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP).
Active involvement in Computer System Validation (CSV) procedures including:
- User Requirements Specifications (URS)
- Functional and Design Specifications
- Support for IQ/OQ/PQ execution
Proven background in the life sciences sector, particularly with authoring and updating SOPs for Information Technology.
Experience preparing and managing change control documentation.
Skilled at operating within cleanrooms and manufacturing areas.
Strong understanding of network architecture, including subnets and WiFi.
Familiarity with Manufacturing 3.0 concepts, including electronic batch records and IoT integration.
Advanced proficiency collaborating with software vendors for Tier 2 and Tier 3 troubleshooting support.
Established record of success with Help Desk ticketing systems.
Technical expertise in desktop support at Tier 2 and Tier 3 levels.
Systems Experience:
Proficient with M365 platform user support, including admin settings, SharePoint, MS Office, Outlook, Copilot, Power Automate, and basic shell scripting.
Shopfloor control systems: Chromatography (AKTA/Unicorn), instrument control (Cytiva/Thermofisher equipment, DeltaV).
Familiar with MES, LIMS, ERP (S/4 Hana or QAD), CRM admin (Salesforce), QMS (Veeva/Master Control), BMS (Siemens/Desigo), asset & calibration systems (Blue Mountain RAM), Chromeleon (HPLC), New Brunswick BioCommand, and Softmax Pro plate readers.
