Job Description :

DigitalTek Solutions is a staffing company providing technical & non-technical recruitment solutions with over 10 years pertaining to the statement of work-based managed services staffing, staff augmentation and IT consulting services to 1000 fortune companies within North America.

Our niche is top-notch talent acquisition for Information technology, Engineering and the Digital sector within banking, financial, insurance, capital markets, telecom, manufacturing, utility & energy and plenty of other domains in NAM and LATNAM regions.

Sponsorship: Our clients will sponsor visa applicants; one must be open to relocate or travel within USA on reimbursed expenses.

Terms: Long term contract and/or Full time/Permanent.

Role: BioComp SME

Location: Warsaw, IN (Remote to start)

Primary skills: Biocompatibility, Analytical chemistry, Risk assessment of manufacturing materials, Polymers and their biocompatibility (Good to have).

·        Competency as subject matter expert in biocompatibility domain

  Working knowledge of analytical chemistry

  Has a comprehensive record of external training in area of competence

  Prior experience with risk assessment of manufacturing materials

  Has proven competency in presenting subject matter to expert groups and key opinion leaders in a clear and convincing matter.

  Has experience in conveying complex scientific topics in a clear and comprehensible fashion.

  Strong problem solving skills.

  Biocompatibility assessment and organization of respective testing for medical devices

  Supporting resolution of biological evaluation issues for current manufacturing facilities and for new product development

  Internal technical document creation and approval

  Supporting Complaints investigations, CAPAs, and other general technical support duties required within the team

  Creating Technical Reviews, specifications and other mandatory documents for regulatory submissions

  Reviewing and preparing of procedures to keep pace with standards development

  Representing the company via presentations to groups of experts, societies, regulatory bodies and at international meetings.

  Helping in development and generating material for staff training and data presentations

  Maintaining relevant scientific and medical knowledge by attending conferences, courses and meetings

  Educating internal colleagues across departments and divisions in the area of biological safety evaluations, risk assessments, and chemical characterization.

  Providing support for key opinion leaders

Client : Major Consulting


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