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At European Recruitment, our sectors cover a wide range of industries within the field of technology
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range of industries within the field of technology
At European Recruitment, our sectors cover a wide
range of industries within the field of technology
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Automation Area Lead
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.Â
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 Area Lead (AAL) will be the client representative in the design of DeltaV application software. The specifications, code, and testing are being developed by a System Integrator (SI), and this AAL 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 for a specific area of the facility (ex: Upstream, Downstream, Utilities, etc).
During the Detailed Design phase, the AAL will guide and review/approve the technical outputs and activities of the System Integrator. The AAL is also responsible for reviewing process design changes and performing impact evaluation for the ongoing DeltaV Software design.Â
The AAL will also be the primary interface between Process Engineers and the SI. Â They will also engage with a Manufacturing Execution Systems Team that is developing MES Software.Â
Responsibilities
- Develop and possess a deep understanding of the process engineering design for their specific process area by working closely with client Process Engineers and Operations Representatives
- Technically lead and oversee the work and work products that the System Integrator produces Including (but not limited to); Functional Requirements Specifications, DeltaV Design Specifications, DeltaV Application Software, Test Specifications.
- Work collaboratively with the System Integrator Engineers and Developers
- 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
- Attend equipment and software FATs
- Lead a team of automation engineers supporting commissioning
- Abide by all safety requirements and procedures pertaining to their role
Requirements
- BS Engineering (or equivalent experience)
- 5 years working experience in Biopharma engineering, operations, or manufacturing
- Prior Process Engineering experience is strongly desired
- Preferable, 5 years’ experience in DeltaV batch automation design and distributed control system design
- Preferable, Instrumentation knowledge
- Preferable, experience with Kneat electronic testing
- Demonstrated teamwork abilities
- Knowledge of GMP’S, regulatory requirements, computer system validation
- Provide periodic status updates to Project Management
- Good written and verbal communication skills for both technical and non-technical audiences
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