Automation Engineer

Indianapolis, IN

Chemical Manufacturing

About the position

Engineering support for automation systems, interfaces and equipment. Responsible for oversight of the automation systems across the facility (building/process/laboratory). Ensures the site's compliance with internal GMP's, CSV and external regulatory requirements. At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced Supply Chain professionals to help us reach our ambitious goals.

Responsibilities

• Oversight of the automation systems at the site including building automation systems (BAS), room monitoring systems (RMS), process and laboratory equipment automation.
• Oversight of the overall automation asset care strategy for the site which includes performing upgrades, maintenance contracts and changes.
• Responsible for the support and execution of automation qualification as well as the resolution of all automation-related issues.
• Ensure cGMP, Data Integrity, and CSV compliance with all internal Novartis and external regulatory requirements.
• Update and develop User Requirement Specifications, Functional Specifications, Design Specifications, Operation and Maintenance for the new and existing control systems.
• Devise new approaches to complex problems through adaptations and modifications of standard automation technical principles.
• Work closely with manufacturing, engineering, utility operations, maintenance, quality assurance, and qualification to manage a diverse portfolio of projects.
• Lead, plan, and execute automation projects from start-up to completion.
• Develop Project Commission Plan / Strategy.
• Manage and resolve project deficiencies and deviations.
• Develop project execution strategy and execute project(s) according to customer needs (costs, schedule, functionality, quality).
• Assist in Preparing Project Initiation Documents (Business Requirements (PBR), Work Breakdown Structure (WBS); Cost Breakdown Structure (CBS), Project Scope Statement (PSS).
• Provide technical support to operations and support personnel.
• Own and close corrective actions related to the automation systems.
• Compliance with technical, quality and legal requirements.
• Reliable runtime of automation systems (minimum downtime).

Requirements

• Bachelor's degree in engineering, computer science, automation, or related field or equivalent relevant experience.
• 2+ years of relevant engineering experience in Chemical, Pharmaceutical or Food & Beverage industry is required.
• Good oral and written communication skills.
• Knowledge of FDA regulations, particularly 21 CFR part 11 and GMP systems.
• Familiarity with industry standards 21 CFR Part 11, Data Integrity, Validation, and GAMP.
• Must be able to work in controlled environments requiring special gowning.
• Extended interdisciplinary technical knowledge.
• Knowledgeable in a GMP regulated environment (pharmaceutical preferable).
• Experience with automation systems (Continuum, Siemens, DeltaV, PLCs, etc).
• Knowledge of IT infrastructure/networks related to automation systems.
• Strong oral and written communication skills.
• Must be able to work well with others in a team environment.
• Strong computer skills.
• Working knowledge of P&ID and loop diagram standards; temperature, pressure, flow, weight, humidity, and other instrumentation.

Benefits

• 401(k) eligibility
• Various paid time off benefits, such as vacation, sick time, and parental leave