SUMMARY
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.
