Catalyx: Provides machine vision and automation solutions for manufacturing.
8+ YOEBachelor's or Master's in engineering,8+ years automation experience in GMP biologics/pharma,strong DCS/PLC/SCADA and MES/LIMS integration skills,knowledge of GMP/GAMP5/ISA standards and CSV,technical leadership.
DCS, PLC, SCADA, ISA-88, ISA-95, MES, LIMS, ISA/IEC 62443, CSV, process historian
Emmes: Provides full-service clinical research and technology-enabled development solutions.
2+ YOE2–5+ years in clinical software QA, CSV, GxP, or validation; experience with GAMP 5, FDA 21 CFR Part 11; strong SDLC knowledge; risk-based validation approach; ability to review and develop validation documents.
CSV, GAMP 5, FDA 21 CFR Part 11, QA documentation, Requirements and design specifications, Validation Plans, Test Plans, Traceability Matrices
Associate Director, Digital & Business Process Strategy
Rockville, Maryland, United States
$122k-$184k/yrOnsiteFull Time
AstraZenecaLondon Stock Exchange: AZN: Researches, develops, and manufactures prescription medicines for major diseases.
8+ YOE3+ MgmtBachelor's degree required, advanced degree preferred; 8+ years in regulated manufacturing/pharma with hands-on MES/historian/LIMS exposure; 3+ years as product owner; strong CSV/GxP knowledge.
Emmes: Full-service clinical research organization supporting biopharmaceutical and public health.
2+ YOEBachelor's degree and minimum 2 years QA/validation experience in regulated industries; knowledge of GxP, CSV, GAMP 5, 21 CFR Part 11, SDLC (Waterfall/Agile); strong documentation and analytical skills.
Waterfall, Agile, Computer Systems Validation (CSV), GAMP 5, 21 CFR Part 11
LonzaSIX Swiss Exchange: LONN: Manufactures medicines and provides development services for healthcare companies.
12+ YOE12+ years leading automation/OT/digital manufacturing in GMP-regulated environments; bachelor's degree in technical discipline (advanced degree preferred); experience with MES, DCS/PLC/SCADA, CSV, data integrity, and cybersecurity; travel ~25-30%.
Dickinson College: Private liberal arts college providing undergraduate degrees and global education.
Coordinate Workday Student integrations, liaise with vendors and consultants, assist with data mapping, validation, and testing; strong communication, analytical, and spreadsheet skills required.
Workday, SFTP, CSV, Microsoft Excel, APIs, web services
ManTech: Provides technology solutions for defense and intelligence agencies.
5+ YOE5+ years software development with Python, experience building/maintaining data pipelines and ETL, Git/GitHub, Bash/Linux, common data formats, data validation and quality controls, and active TS/SCI with Poly required.