Computerized Systems Validation Engineer

Kelly Services is seeking a Computerized Systems Validation Engineer role for a multinational biotechnology company.

Job Title Computerized Systems Validation Engineer Location Remote Type W2 Assignment Length 06 monthsrsquo Pay rate Open for discussion The main responsibility of the Computerized Systems Validation Engineer ndash BES (Biogen Execution Systems) is to perform computer systems validation activities associated with ensuring that business processes required to operate a highly automated integrated large scale bio-production facility in Solothurn, Switzerland are qualified against company directives and procedures.

The new facility and the production process in Solothurn is highly automated with data being shared across multiple platforms to support production, from raw material receipt to disposition of the produced drug substance.

Data generated at each stage of production is shared across business information and control systems.

The incumbent is expected to have good knowledge of change management and change control of highly integrated recipe IT systems.

The incumbent understands industry-wide and Regulatory expectations for computer system validation, and works with other members of IT and Site organizations to ensure that Computerized System Validation (CSV) packages are consistent with validation plans and standard operating procedures and utilizes industry experience to identify continuous improvement opportunities of site BES IT CSV practices.

Responsible for executing the SOL BES validation strategy and lifecycle management (NGLSM) Next Generation Large Scale Manufacturing project reporting into the Senior Manager of SOL BES CSV.

Responsible for driving activities influencing beyond respective department.

Executes standard practices, processes and procedures for group department program.

Erroneous decisions may impact the business unit.

Applies discretion and experience to handle unique difficult situations.

Works in collaboration with some direct supervision while driving projects to conclusion.

Provides a junior level of consultation to management.

1.

Perform validation activities at the Solothurn site and ensures the approach and execution aligns to Biogen expectations.

Scope includes IT, Execution Systems, and Laboratory Analytical systems.

55 2.

Provide input on improvement of testing documentation.

15 3.

Support the implementation and adoption of the global CSV program and remediation.

Support data integrity implementation and remediation for systems within CSV program.

Participate in continuous improvement efforts related to CSV program.

15 4.

Support the BES organization to achieve all CSV site and corporate goals.

15 Requirements Bachelorrsquos Degree (BS) from a four (4) year college or university with as emphasis in EngineeringSciences or equivalent.

5-10 years related experience andor training or an equivalent combination of education and experience.

bull Ability to complete tasks with limited oversight bull Understanding of regulations governing computer systems and control such as FDArsquos 21 CFR Part 11, EMArsquos Annex 11, and MHRArsquos data integrity guidance bull Understanding of modern and risk based validation executions bull Background in Lifesciences andor PharmaBiotech industries (or understanding of bioprocessing and support processes) bull Direct experience with IT and MFG automation systems supporting GMP manufacturingAnchor .

If this position may be interested to you, please email me back at somp767kellyservices.com (with your most up to date resume in word format) and advise the best time and number at which you can be reached Thanks Soma Patanaik Professional Technical Recruiter Kelly Services, Inc Somp767kellyservices.com