Teamlead in Automation Engineering focusing on device manufacturing at a successful medical technology company. Leading expert teams and ensuring GMP compliance for manufacturing processes in Stuttgart area.
About the role
- Automation Engineer IV supporting cGMP manufacturing at OXB in Durham, NC. Technical support for automation systems and compliance adherence in a biotechnology company.
Responsibilities
- Planning, execution, and monitoring of Automation systems utilized on site for cGMP manufacturing and facility utilities.
- Provide technical support for automation projects, including automation system design, control system hardware, equipment design, control panel design, alarm management, and instrumentation start-up and troubleshooting.
- Support development of technical standards, guidelines, and procedures in accordance with industry best practices.
- Support automation system design and integration, including hardware/software design specification development, user / functional requirement development, integration, and validation in conjunction with IT Computer Systems Validation & QA Validation leads.
- Develop P&IDs and loop descriptions for various processes, and/or equipment.
- Partner with automation system service providers, contract resources and Instrument/Electrical technicians ensuring safe, compliant maintenance and project execution.
- Maintain current contacts as needed for system support.
- Support automation issue identification, communication, and resolution, including all compliance aspects such as Deviation investigation, Change Control, Corrective and Preventative Action (CAPA).
- Provide technical support for troubleshooting, improving, or optimizing ongoing manufacturing operations, including being on-call for after-hours remote support.
- Support the design, configuration, administration and maintenance activities of the site's manufacturing computer and automation systems, including process control systems, building automation systems, manufacturing execution systems, and data historians.
- 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 manufacturing cGMP operation with flexibility to support operations on off hours.
Requirements
- Requires a BS/MS in Engineering or related field
- Must have 8+ years of experience working in a biotechnology company, with focus on cross functional support for cGMP manufacturing
- 8+ years of experience in the execution of the automation discipline in a regulated manufacturing environment
- Strong understanding of GMPs and good engineering practice (GEP), including ISA S88, GAMP, ASTM E2500, ISPE guidance, etc.
- Experience with HMI/SCADA packages such as: Rockwell RSView, FactoryTalk.
- Experience with OSI PI.
- Experience with PLCs such as: Rockwell, Siemens.
- Experience owning SOPs, deviations, change controls, and CAPAs to support operations.
- Experience in plant start up, equipment commissioning, and qualification is a plus.
- Experience with recipe design and qualification for bioreactors or chromatography skids is a plus.
- This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.
Benefits
- Competitive total reward packages
- Wellbeing programs that support your mental and physical health
- Career development opportunities to help you grow and thrive
- Supportive, inclusive, and collaborative culture
- State-of-the-art labs and manufacturing facilities
- A company that lives its values: Responsible, Responsive, Resilient, Respect
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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