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Automation Technical Lead Engineer
Excellent opportunity to join project design team on a major biotech construction project developing design for an advanced biotech manufacturing facility. This design includes bioprocessing upstream and downstream as well as associated support areas and utilities. This facility will take advantage of single use systems to deliver a state-of-the-art facility incorporating new technologies to support their client’s rapidly expanding monoclonal portfolio with a specific focus on operational flexibility, environmental sustainability and fast-track delivery concepts.
The facility automation design will be fully automated with batch sequencing and recipes using a Delta V distributed control system. The project is currently starting Detailed Design phase and will be for the next 18 to 24 months.
This is a GMP facility, and all engineering activities will be performed in a manner consistent with project computer system validation and documentation practices.
The Automation Technical Lead (ATL) will represent the client overseeing the design of the Delta V Application Software development. The specifications, code, and testing are being executed by a System Integrator (SI), and this ATL role is to provide technical oversight of the SI, review and approve documents and DeltaV application software the SI produces, and in general represent the client’s interests.
During the Detailed Design phase, The ATL will have primary oversight and review/approval responsibility for the System Integration generated Delta V design standards, module library design, phase and equipment module shells/templates, and batch/recipe conventions/approaches. This is a senior level role for the client-side Delta V team, and the ATL will work closely with the client Delta V technical lead. The ATL should have experience integrating DeltaV with Manufacturing Execution Systems (MES).
The ATL is also responsible for establishing standard work practices with the SI, such as configuration management practices, source code review practices, testing practices, and will have responsibility for reviewing, evaluating, and impact assessments of process design changes.
The ATL is also a technical coach and mentor to (3) client-side Automation Area Leads (Upstream, Downstream, Utilities/Support). These client-side Area Lead Engineers have primary responsibility for the System Integration developed requirements and design specifications, application software, etc for their specific area. The ATL will at times, need to review, advise, and assist on the work these Automation Area Leads are doing.
§ Possess a deep understanding of the process engineering design for Biopharma processing and working closely with client Process Engineers and Operations Representatives.
§ Possess a deep understanding of Delta V control system design in the pharmaceutical industry.
§ Technically Lead and oversee work and work products the System Integrator produces, Including technical standards, work processes, module templates, phase templates, procedural and recipe design conventions, Delta V integration approaches to MES.
§ Work collaboratively with the System Integrator Engineers and Developers
§ Work collaboratively and technical coach/mentor the client Automation Area Leads.
§ Lead/Participate in design reviews and Delta V application software reviews
§ Proactively work with the Computer System Validation Engineer to ensure deliverables and work practices comply with the project validation and documentation requirements
§ BS Engineering (or equivalent experience)
§ 10 years working experience in Biopharma engineering, operations, or manufacturing
§ Prior Process Engineering experience is strongly desired
§ Preferable, 10 years’ experience in DeltaV batch automation design and distributed control system design
§ Preferable, Instrumentation knowledge
§ Demonstrated technical leadership and teamwork abilities
§ Knowledge of GMP’S, regulatory requirements, computer system validation
§ Good written and verbal communication skills for both technical and non-technical audiences