Technical Source is looking for Delta V engineer who will be responsible for the implementation, validation, qualification and maintenance of the ISA-95 level 1 and 2 manufacturing automated systems and applicable interfaces and level 3 recipe content for a manufacturing facility. Ensure that automated systems are fit for intended use and follow applicable regulatory requirements (e.g. cG(a)MP) and company manufacturing standards throughout the entire system life cycle.

The Automation Engineer, Delta V supports the design and maintenance of site’s Delta V systems, including project execution, upgrades, system performance, vendor management, production and development systems, library standards, and Delta V network infrastructure.

Key Responsibilities:

• Support the automation systems – Delta V.
• Support project execution as a project team member and lead complex projects.
• Implement or lead execution system code change.
• Write and perform validation protocols.
• Ensure compliance with global standards.
• Support risk assessments.
• Support investigations.
• Participate in compliance inspections.
• Ensure sound technical engineering concepts are applied in all tasks.
• Delivery and execution of the Site Delta V strategy.
• Utilizes industry experience to identify continuous improvement opportunities of site validation practices.

Qualifications

Education:

• Bachelor’s degree in Engineering, IT, Science or related discipline is required.

Required:

• Two to five years of experience in a manufacturing environment, biopharmaceutical or pharmaceutical industry, or an equivalent combination of education and experience.
• Hands-on experience in Emerson Delta V and Delta V Batch Control
• Knowledge of Industrial Automation Networks and their Communication Protocols (PROFINET, EthernetIP, ModbusTCP, etc.)
• Understanding of the ISA S95 & S88 standards and how they should be used within the Global Supply Chain.
• Understanding of OSI PI Historian and MES (Werum preferred).

Preferred:

• Knowledge of S95 Level 1 systems such as OSI Pi, PLCs, IT Infrastructure & Hardware, and MES, preferred
• Understanding of S95 level 4 systems and their capabilities such as ERP, Quality Systems, Data warehouses & CDL.
• Knowledge of cGMP regulations related to CSV including 21 CFR Part 11 and EU GMP Annex 11.
• Good communication & organizational skills when working within cross-functional teams, demonstration task ownership
• Proven experience within a pharmaceutical or GMP regulated manufacturing environment in an Execution Systems, Automation or IT role.
• Experience in supervision/management of people and resources.
• Project Management certification and/or experience
• Process knowledge for Upstream, Downstream and Bio Processing Support functions.
• Proven understanding of GAMP 5 and other recognized industry standard methodologies.
• Good appreciation of Industry 4.0/IoT
• Good understanding of the developing Digital World to transform Biopharma