Fluidigm

Senior Design Transfer Scientist

Job Locations CA-ON-Markham
Req No.
2018-2615
Category
Quality Assurance / Regulatory
Type
Regular

Job Description

The Senior Design Transfer Scientist supports the co-ordination of product Design Transfer projects involving interaction with various departments and company sites in order to provide high quality reagents. This requires technology transfer activities to enable robust and reproducible manufacture of existing product ranges, including process improvements and development of new products.

 

Essential Duties and Responsibilities

Position Responsibilities/Essential Functions

  • Work closely with various functional areas to co-ordinate the Design Transfer activities to transfer new or improved products and processes into Manufacturing.
  • Act as liaison between Operations and R&D.
  • Independent technical support and decision making for methods with complexity.
  • Develops design verification and validation test plans and protocols for new or modified products.
  • Co-ordinate implementation of complex procedures and training others.
  • Prepares technical reports and leads cross-functional technical reviews.
  • Assist with the preparation of all types of product development documentation in order to meet the departmental objectives and to comply with Regulatory requirements.
  • Support the co-ordination of risk management (FMEA) and Critical to Quality Analysis, including the preparation of process maps, to ensure that the required latitude and validation studies are performed during new product development and that robust processes are transferred to manufacturing.
  • Assist with the planning of new product and process developments and input knowledge of existing products and processes.
  • Support process improvement initiatives related product development to ensure robust processes are transferred to Manufacturing.

Minimum Job Requirements:

  • BS in Chemistry/Biochemistry or related discipline with 7 years related industry experience (cytometry preferred) or advanced degree in Chemistry/Biochemistry discipline with 5+ years related industry experience.
  • Experience in manufacturing, product transfer or product support functions.
  • Good understanding of ISO 13485 standard in general and Design Control elements specifically.
  • Demonstrated ability and proficiency in the development and execution of equipment qualification protocols (IQ, OQ, and PQ), process validations, software validations and other validation lifecycle documents.
  • Experience in preparing manufacturing documents including SOPs, specification sheets and worksheets, with good working knowledge of manufacturing-related drawings, machine specifications, and required test equipment/fixtures.
  • Demonstrated ability for scientific creativity, problem solving skills, collaboration with other departments, and ability to manage multiple projects or assignments.
  • Ability to read, analyze, and interpret common scientific and technical reports, technical procedures, validation protocols and reports, operating instructions, scientific publications, general business periodicals, or governmental regulations.
  • Attention to details.
  • Ability to present and communicate (oral and written) information in a clear manner.
  • Proficiency with Microsoft Office, including Word, Excel and Powerpoint.
  • Travel required - less than 10%.

 

The Company is committed to providing an inclusive and barrier free recruitment process to applicants with accessibility needs in accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act (AODA). If you require an accommodation during this process, please inform The Company of your requirements.  We are an equal opportunity employer.

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