Senior Engineer Instrumentation & Calibration
Biogen
Luterbach, Switzerland
vor 2 Tg.

Job Description

Designs, specifies, and installs new Manufacturing Process and Laboratory Analytical instrumentation. Provides engineering technical support and troubleshooting for all utilities, cell culture, purification, and laboratory equipment.

Provides project engineering as required for new instrumentation & installations and modifications to existing equipment.

Aid in the development of junior I&C Technicians. Able to manage small to medium engineering projects. Work with and provide some direction to contractors.

Participate in multi-function site & global teams to implement change and improve on existing processes.

Subject matter expert of the hardware and software of complex automation system platforms (e.g. : DeltaV) and / or centralized data archive systems (e.

g. : OSI Pi) linked to instrumentation and controls.

Creates design specifications, manages the implementation of new control strategies, and develops software test protocols in support of new process automation and / or laboratory for all instrumentation.

Responsible Engineer (RE) duties which require FAT’s, commissioning, and assuring current engineering documentation (e.g.

URS, DS, protocol review, change controls, support tech transfer) related to instrumentation.

Drives I&C departments development, reliability, quality identifies and implements continuous improvement initiatives for process optimization, drives solutions for software / hardware instrumentations problems, and supports system troubleshooting of business-critical automation controls and instrumentation.

Support development of I&C engineers, SME, junior technicians. Able to manage medium sized engineering projects.

Participate in multi-function / global teams to implement change and improve on existing processes. Works with other site and global functions to communicate issues and resolutions

Qualifications

Process I&C troubleshooting and investigations for both GMP and Non-GMP manufacturing and laboratory instrumentation systems.

Authoring deviations, CAPA’s and / or change control records in a GMP environment as well as updating instrumentation & control panel drawings.

Configure Instrumentation & Control systems including utilities, process & laboratory instrumentation, control system hardware, and related software (i.

e. : Delta V, DCS, SCADA, DAS, Smart Instrumentation and PLC systems). This includes both the systems software & related hardware under the scope of the I&C department.

Design, specify and oversee implementation and testing activities of new manufacturing process and laboratory analytical instrumentation.

Expert in CRA process (Critical Risk Analysis). Provide project support and / or project management for capital projects and global initiatives to implement new facilities, equipment, and instrumentation.

Source and supervise I&C contractors as needed.

Identifies needed enhancements (site and shared globally) and leads projects related to instrumentation, hardware and software upgrades utilized on process and utility systems including interim supervision of I&C technicians and support of FAT activities.

Oversee lifecycle management for instrumentation systems and equipment. Implement instrumentation upgrades and continuous improvements

Support validation, engineering, Tech transfer, quality, regulatory, and safety activities to ensure compliance with Biogen’s policies and procedures.

Represent I&C department and participate in cross-functional and global teams to address issues, implement change and improve existing processes.

Lead / participate in cross-functional / global teams to address issues, implement change and improve existing processes

Process engineering support including process improvements, process troubleshooting, determining instrumentation & automation requirements, as well as supporting the development of new improved process control and logic strategies.

Provide additional site and global day-to-day technical support which may include one or more of the following : Troubleshooting, site & cross-site collaborations / meetings, system user access, configuration changes, new points or control blocks, control wiring, supporting of upgrades and software hot-fixes, disaster recovery support, off-shift call support, etc.

Identifies gaps and enhancement opportunities (site and globally) and leads projects related to automation hardware and software upgrades, and instrumentation utilized on process and utility systems including interim supervision of site and external technicians in support of I&C activities.

Administrative support aligned with GEP (Good Engineering Practices) such as assuring SIA (System Impact Assessments), URS (User Requirement Specifications), DS (Design Specifications), P&ID Drawings, etc.

are current. Authors Standard Operating Procedures, Work Instructions / Job Aids, and LOTO JP’s for both Automation and Calibration activities.

CMMS administrative activities (e.g. : Onboarding of new Systems & associated Measurement Devices, CRA’s, Category development, Checklists, Job Plans, SME approvals, etc.).

Oversee lifecycle management for automation systems & instrumentation. Implement automation upgrades linked to instrumentation continuous improvements.

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