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Automation Engineer UTC

Sanofi Group
Waterford
40 days ago: Sanofi Group

Job Description

Description

 

Reporting position

Reports to I&AT Manufacturing Systems Manager

Working relationship

Interfaces with internal ‘end users’ Manufacturing, Facilities, Maintenance and Quality

Interface externally with engineering consultants, major equipment vendors, solution providers (e.g. Siemens) and Corporate Engineering functions

The I&AT Group provide customer support to the Waterford business areas for automation and IT products, services and applications on new and existing systems and resolving and reporting associated problems

Purpose of Role

To provide high level Automation support to operations as a back up to maintenance

To ensure our automation systems are kept in a compliant manner

To deliver process or technology improvements

Job Requirements

Writing and maintaining SOP for Automation Systems.

Maintain the PLC Automation Systems in a validated state according to the GAMP 4 / cGMP Guidelines

Through effective change control procedures ensure that changes carried out on the PLC Automation Systems do not compromise the safety

Environmental or quality stance of the Waterford plant.  Ensure that the applications software design concepts & standards are maintained during modifications & enhancements

Work with Automation Team lead to plan PLC Automation Systems service, support & project resources/funding.  Input to Department budget and develop estimates for new capital & expense work

Provide technical support & guidance to Maintenance & Facilities in their role and other engineers working on project development.  Manage contract resources as necessary

Act as the Automation support contact with manufacturing for Fill Finish, Oral Dose, Packaging, Projects, Maintenance, & Facilities.  (e.g. Pack lines, BMS, Scada, etc)

Identify, evaluate & implement opportunities for continuous improvement of the PLC Automation Systems applications suite and departmental business processes

Support the Project Execution Process through review of relevant documents & preparation for handover of applications to Maintenance & Facilities for support during the Operation phase of their lifecycles

Support in commissioning/start-up operations to ensure that all equipment brought on site is integrated into the current systems/procedures

Compliance Related Tasks

Ensure that changes carried out on Automation Systems do not compromise the safety, environmental or quality compliance status

Ensure compliance to cGMP at all times

Qualifications

 

Engineering degree (Electrical/Electronic) or equivalent

Experience

3-5 years experience in a pharmaceutical control systems operational and/or project engineering role (with specific control focus)

Plant commissioning and validation

Validation documentation generation/review and Software protocol execution

Experience of UMS, BMS and EMS systems – their specification, testing, commissioning and validation

Experience of engineering consultant and solution provider co-ordination

Experience of tableting and/or sterile vial fill an advantage but not essential


Skills & Knowledge

Excellent technical knowledge with good operational and/or project engineering experience i.e. all phases of the GAMP life cycle, validation phases, final hand-over and training

Control system validation FAT to PQ (protocol generation, review, execution and reporting)

GAMP 4/cGMP requirements

Siemens S7 PL C and SCADA experience

Excellent interpersonal skills



Job

:   Engineering & Maintenance

Description   Reporting position Reports to I&AT Manufacturing Systems Manager   Working relationship Interfaces with internal ‘end users’ Manufacturing, Facilities, Maintenance and Quality Interface externally with engineering consultants, major equipment vendors, solution providers (e.g. Siemens) and Corporate Engineering functions The I&AT Group provide customer support to the Waterford business areas for automation and IT products, services and applications on new and existing systems and resolving and reporting associated problems   Purpose of Role To provide high level Automation support to operations as a back up to maintenance To ensure our automation systems are kept in a compliant manner To deliver process...