Job Opportunity:
We are seeking a highly skilled and experienced Tech Project Engineer to join our team. As a key member of our Technology Projects Team, you will play a crucial role in delivering complex system technology initiatives and projects.
**Key Responsibilities:**
* Support the entire technology system project lifecycle, from solution design to GMP qualification.
* Project management and execution of assigned projects, including project prioritization, resource management, status reporting, and external communication.
* Collaborate with various stakeholders to scope projects and ensure requirements are satisfied.
* Critically analyze system design, develop, and recommend continuous improvements in line with the latest technology and regulatory standards.
* Work effectively within cross-functional teams.
Requirements:
* Bachelor's degree in electrical engineering or computer science, chemical engineering, biotech engineering, or a related life science engineering field, with 5+ years of experience in operations/manufacturing environments.
* Manufacturing automation experience in biopharmaceutical formulation/fill/finish or active pharmaceutical ingredient (API) facilities.
* Excellent control systems automation background, focusing on design, installation, programming, validation, and lifecycle maintenance of automated equipment.
* Experience with PLC programming and troubleshooting, SCADA, PCS, and batch systems.
* Familiarity with industrial networking, including ControlNet, DeviceNet, Profibus, etc.
* Proficient in using automation support tools like RSLinx, RSNetworx, FactoryTalk AssetCentre, ThinManager, and OSIsoft PI Data Historian.
* Knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards, 21 CFR Part 11, and Annex 11.
* Working knowledge of network architecture technologies, including TCP/IP, routing, switching, network IDS/IPS, Active Directory, domain integration, and firewalls.
* Solid leadership, technical writing, and communication/presentation skills.
* Experience in change control, non-conformance, corrective, and preventative actions, and validation practices.
* Ability to translate strategic opportunities and emerging technology solutions into actionable plans.
This is an exciting opportunity for a motivated and detail-oriented individual to contribute to the success of our organization. If you are a results-driven professional with a passion for technology and a commitment to excellence, we encourage you to apply.