Automation Technical Lead (ATL)

A major pharmaceutical company is developing design for a 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 the 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 DeltaV distributed control system.  The project is currently starting Detailed Design phase and will be in that phase for the next 18 to 24 months. 

This is a GMP facility, and all engineering activities below will be performed in a manner consistent with project computer system validation and documentation practices.

Purpose of the Role
The Automation Technical Lead (ATL) will represent the client overseeing the design of the DeltaV 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 DeltaV 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 DeltaV team reporting to the Automation Project Manager, and the ATL will work closely with the client Project Engineering discipline leads, Commissioning and Operations representatives.  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 (upto 6) 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.

Responsibilities

• 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 DeltaV control system design in the pharmaceutical industry.
• Technically Lead and oversee the work and work products that the System Integrator produces. Including (but not limited to):  technical standards, work processes, module templates, phase templates, procedural and recipe design conventions, DeltaV 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 DeltaV 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
• Abide by all safety requirements and procedures pertaining to their role

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
• Interface regularly and provide formal and informal project status updates to Project Management
• Good written and verbal communication skills for both technical and non-technical audiences