Responsible Engineer Calibration

Description

Responsible Engineer Calibration (m/f)

Location: Solothurn, Switzerland

Start date: as soon as possible

Duration: until December 2018

Remote: no

Job Summary:

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 with little direction. Work with and provide some direction to contractors. Participate in multi-function site & global teams to implement change and improve on existing processes.

General tasks:

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).

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: able to analyse sensor life in order to maintain high confidence level.

Support validation, 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.

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

Knowledge and skills:

• Practical knowledge and application of GMP and EMEA regulations.
• Eight years' experience in pharmaceutical or biotech manufacturing environment
• Knowledge of industry standards and guidelines, e.g., ISA 5.1, GAMP, S88.01, S95 and CFR's.
• Prior experience in engineering, construction, commissioning or validation of capital projects for the biotech/pharmaceutical industry.
• Prior experience with DeltaV, OSI PI, Rockwell automation PLC's and Intellution HMI's and the ability to program/configure these systems.
• Ability to read and understand electrical drawings and instrumentation datasheets/schematics.
• Experience with enterprise/IT systems.
• Working knowledge of equipment associated with the biotech/pharma industry.
• Prior experience managing projects including directing contractors.
• Excellent oral and written communication skills.
• Able to balance resources and time between projects of variable size and complexity.

If you are interested in that position please send your updated CV to or give or me a call on . If you are not interested please share this opportunity also with your network.

Looking forward to hearing from you

Regards

Kaja

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.