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    6 days ago

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    3 weeks ago

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    7 days ago

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    Culver City, United States VeeAR Projects Full time

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  • Field Service Engineering II

    3 months ago

    Salt Lake City, United States 923 FLSmidth Inc. Full time

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Engineer II, Automation

2 months ago

Oklahoma City, United States Edmond Pharma S.R.L. Full time

ReciBioPharm is looking for a highly motivated Automation Engineer II that is looking to join a growing Automation team. The Automation Engineer II is responsible for implementing and maintaining the control systems used for ReciBioPharm’s Quality Control, Process Development, and Manufacturing facilities in Watertown, MA. This position will provide engineering support for utilities, process, and lab equipment used in the execution of day-to-day operations, projects, and troubleshooting. This position will report to the Automation Manager. The individual will work closely with the end users of these control systems, including Quality Control, Process Development, Engineering, Validation, Manufacturing, and Facilities. The individual will occasionally supervise contractors and vendors within the scope of automation. ESSENTIAL RESPONSIBILITIES Provide technical support for control systems throughout the facility, including quality control instruments, clean utilities, process development equipment, GMP manufacturing systems, and the building automation system. Administer systems, serve as a data integrity SME, and support periodic reviews for computerized systems. Troubleshoot equipment using root cause analysis techniques, own Corrective/Preventative Actions and associated change controls, provide input into preventative maintenance plans, assess change controls, and develop continuous improvement initiatives. Provide a high level of customer support to the Facilities, Process Development, Quality Control, and Manufacturing teams. Collaborate cross-functionally with stakeholders to determine the best path forward to identified issues by balancing technical, compliance, and business objectives. Complete projects in compliance with quality processes and meet project timelines to ensure the production schedule is not impacted. Demonstrate a proactive safety and quality mindset while completing assignments. Initiate change controls, incidents, and CAPAs within the quality management system. KEY CHARACTERISTICS Excellent interpersonal and communication skills (verbal and written) Ability to present work to peers and cross-functional managers Ability to interact well with other groups Willingness to take ownership of tasks and drive them to completion Ability to implement changes with general direction from their manager Skilled at gathering information and identifying solutions using all available resources Effective prioritization and multi-tasking ability REQUIRED EXPERIENCE Familiarity with biotechnology or quality control operations, including GMPs and data integrity. Familiarity with common computer programs and features, such as MS Office, Windows configuration settings, domains, servers, and network drives. Ability to use their technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions. Ability to represent ReciBioPharm’s interests, objectives and policies in a professional and responsible manner. A minimum of two years of professional experience in Life Sciences or a similar industry. Bachelor’s degree in Automation, Electrical, Chemical, Mechanical Engineering, Computer Science or equivalent experience. Minimally, one of the following:

DCS and/or PLC coding experience including but not limited to DeltaV, Allen Bradley PlantPAx, Allen-Bradley ControlLogix, GE iFix, Unicorn, and/or Siemens Experience configuring systems for domain authentication, automated backups, and multiple user access levels

DESIRABLE EXPERIENCE Understanding of IT infrastructure and networking (VMs, servers, firewalls, switches, domains) Understanding of regulatory FDA Part 11 and European Annex 11 requirements and experience applying these standards to the qualification of control systems Familiarity with systems such as ESXi, MES, LIMS, ELN, and/or OSI PI Understanding of instrumentation, electrical standards, and local requirements Previous experience working in commissioning and validation, including familiarity with user requirement specifications, functional design specifications, change controls, CAPAs, and SOPs PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Moving around the work site using pathways/ramps provided Communicating with others to exchange information Use of office equipment such as computers, telephones, and filing systems Remaining in a stationary position (i.e., seated or standing if able) for prolonged periods Adjusting or moving objects weighing up to 25lbs Repetitive motions that may include wrists, hands and/or fingers. Wearing appropriate PPE in a manufacturing and/or laboratory environment

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