Senior Automation Engineer (US)
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Benefits offered by this job
Job summary
Qualifications
- 5+ years of experience in FDA regulated pharmaceutical or biotechnology industry.
- Experience in pharmaceutical lifecycle, including commissioning and qualification.
- Ability to evaluate automation systems for compliance with standards.
- Strong understanding of cGMPs and GEP; familiarity with ISA88, GAMP, ASTM E2500, ISPE.
- Able to evaluate automation systems for compliance including 21 CFR Part 11, EU Annex 11.
- Troubleshooting hardware and software in 24x7 GMP operations.
Responsibilities
- Develop and deliver automation solutions for clients.
- Manage and lead project teams for successful implementation.
- Support design and maintenance of manufacturing automation systems.
- Create hardware and software design documentation.
- Analyze user requirements to ensure compliant automated systems.
- Validate systems through user test case execution.
Skills
Education
Tools
Job description
Application deadline: Ongoing
Location: USA
Join Confirm as a Senior Automation Engineer and you will be part of a pro‑active team that shares experience and technical expertise across many different disciplines.
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 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 success implementation. You will utilize your tenured experience to provide leadership to your colleagues, providing them with valuable knowledge of effective strategies. As a Confirm Senior 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
- Leadership of 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.
- Analysis and identification of client-specific needs and requirements to ensure deliverance of quality automation solutions.
- Management of automation solutions and identification of bottlenecks, key factors, etc.
To be successful in the role of Automation Engineer at Confirm, we expect you to have:
- BS/MS in Engineering or Equivalent Degree
- 5+ 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, including system architecture
- Experience with HMI/SCADA packages such as: Rockwell FactoryTalk or Siemens products, including system architecture
- Experience with OSI PI Historian or other historians and how data collection systems are configured within the defined ecosystem
- Experience with PLCs such as: Rockwell, Siemens
- Experience with Agile project management
- Experience with Oracle or MS SQL
- IT competencies with understanding of domain requirements, networking, firewall limitations, and system grouping
- Experience in pharmaceutical lifecycle, including commissioning, qualification, and decommissioning
- Strong and proven problem-solving skills
- Attention to detail and dedication to providing superior service
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% vestment 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.
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