Automation Engineer

Job Description

Job Description

Technical Source prides itself on providing superior automation and validation solutions to our customers within the pharmaceutical industry, using our extensive experience to bridge the gap between the two disciplines. We strive to provide our employees with an environment where their personal and professional development are at the forefront of all of our decisions.

As an Automation Engineer, you will be responsible for developing and delivering automation solutions to our clients on a project basis, utilizing coordination and leadership with both internal and external teams to ensure successful implementation. You will utilize your experience and data analysis skills to identify effective automation solutions based on the needs of the team. As a Technical Source Automation Engineer, you will be part of a proactive team that shares experience and technical expertise across many different disciplines.

Responsibilities

• Partner with fellow Engineers to interact as a team with client resources and vendors, such as automation engineers, system service providers, other external resources, and project management.
• Support the design, configuration, implementation, and maintenance of manufacturing computer and automation systems, including process control systems.
• Develop and implement automation solutions as defined by the client's specifications.
• Technical writing of hardware and software design specifications.
• Analyze user and functional requirements to ensure adherence of requirements within automated systems.
• Validate automated systems through user test case execution.
• Adhere to both global and local standards, guidelines, and procedures as defined by our customer, its clients, and industry standards and best practices.
• Advance personal knowledge base by seeking additional training opportunities within different systems.
• Analyze and identify client-specific needs and requirements to ensure delivery of quality automation solutions.

Required Qualifications

• 2–4 years of experience working in a FDA-regulated pharmaceutical, biotechnology or other GMP environment industry
• Experience as a technical team member
• Experience with Emerson DCS (DeltaV), ABB, or Siemens DCS products
• Experience with OSI PI Historian or other historian systems (preferred, not required)
• BS/MS in Engineering or equivalent degree
• Strong understanding of cGMPs (current Good Manufacturing Practices) and GEP (Good Engineering Practices) including ISA88, GAMP (Good Automated Manufacturing Practices), ASTM E2500, ISPE (International Society for Pharmaceutical Engineering) guidance, etc.
• Ability to function within a team setting with assigned tasks
• Ability to evaluate automation systems from a compliance perspective and ensure adherence to applicable standards (e.g., 21 CFR Part 11, EU Annex 11)
• Troubleshooting experience, both hardware and software, in a 24×7 manufacturing cGMP operation
• Experience with Agile project management
• Strong and proven problem-solving skills
• Attention to detail and dedication to providing superior service
• Experience in equipment startup, commissioning, and qualification