Automation Engineer (US)

About the job

Confirm Automation & Validation 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 success implementation. You will utilize your experience and data analysis skills to identify successful automation solutions based on the needs of the team. As a Confirm Automation Engineer, you will be part of a pro-active team that shares experience and technical expertise across many different disciplines.

You will, among other things, work with

Partner with fellow Confirm 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.
Developing and implementing automation solutions as defined by the client's specifications.
Technical writing of hardware and software design specifications.
Analysis of user and functional requirements to ensure adherence of requirements within automated systems.
Validation of automated systems through user test case execution.
Adherence to both global and local standards, guidelines, and procedures as defined by Confirm, its clients, and industry standards and best practices.
Advancement of own knowledge base by seeking additional training opportunities within different systems.
Analysis and identification of client-specific needs and requirements to ensure deliverance of quality automation solutions.

The ideal candidate

To be successful in the role of Automation Engineer at Confirm, we expect you to have:

BS/MS in Engineering or Equivalent Degree
2-4 years of experience working in FDA regulated pharmaceutical or biotechnology industry
Experience as a technical team member
Strong understanding of cGMPs and Good Engineering Practices (GEP), including ISA88, Good Automated Manufacturing Practices (GAMP), ASTM E2500, ISPE 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 (i.e. 21CFR Part 11, EU Annex 11)
Troubleshooting experience, both hardware and software, at a 24×7 manufacturing cGMP operation
Experienced with Emerson DCS (DeltaV), ABB or Siemens DCS products.
Experience with HMI/SCADA packages such as: Rockwell FactoryTalk or Siemens products
Experience with OSI PI Historian or other historians.
Experience with PLCs such as: Rockwell, Siemens
Experience with Agile project management
Strong and proven problem-solving skills
Attention to detail and dedication to providing superior service
Experience in equipment start up, equipment commissioning and qualification

What do we offer?

At Confirm, we value a strong social community, and believe our people are our most valuable assets. Our culture encourages our employees to make the positive decisions that not only benefits them as an individual, but the team as a whole. Additionally, we provide an organizational structure that provides direct access to decision-makers, allowing for total contribution and collaboration. In addition, we offer our teammates the following:

100% paid medical, dental and vision healthcare.
Flex-Time accrual
Five weeks paid vacation per year
12 paid holidays per year
Up to 5% 401K Contribution Matching with 100% vesting day one
Paid Parental Leave including 12 weeks paid paternal leave
Competitive pay

Interested?

Send your CV along with a few words about yourself. If you have any questions about the position, feel free to reach out.

We look forward to hear from you.