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 a Senior 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 tenured experience to provide leadership to your colleagues, providing them with valuable knowledge of effective strategies. As a Senior Automation Engineer, you will be part of a proactive team that shares experience and technical expertise across many different disciplines.

Responsibilities

• Lead fellow Technical Source 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.

• Perform 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 Technical Source, its clients, and industry standards and best practices.

• Analyze and identify client-specific needs and requirements to ensure delivery of quality automation solutions.

• Manage automation solutions and identify bottlenecks, key factors, and improvement opportunities.

Required Qualifications

• BS or MS in Engineering or equivalent degree

• 5+ years of experience working in the FDA regulated pharmaceutical, biotechnology or other GMP environment industries

• Experience with Emerson DCS (DeltaV), ABB, or Siemens DCS products, including system architecture

• Experience with OSI PI Historian or other historian systems and how data collection systems are configured within the defined ecosystem (preferred, not required)

• Experience with Agile project management

• Experience with Oracle or MS SQL

• Experience as a technical team member

• Strong understanding of cGMPs and Good Engineering Practices (GEP), including ISA88, Good Automated Manufacturing Practices (GAMP), ASTM E2500, and ISPE guidance

• 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 such as 21 CFR Part 11 and EU Annex 11

• Troubleshooting experience, both hardware and software, within a 24/7 manufacturing cGMP operation

• IT competencies including understanding domain requirements, networking, firewall limitations, and system grouping

• Experience within the pharmaceutical lifecycle including commissioning, qualification, and decommissioning

• Strong and proven problem-solving skills

• Attention to detail and dedication to providing superior service