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Working at R.S NESS Group means dealing with the top technologies in one of the most appealing fields in todays challenging industry environment. At R.S NESS you will enjoy a dynamic, diverse and innovative work environment, with great team spirit. These are our current vacant positions:

The role includes managing the planning and execution of engineering projects, including the setup of production lines, suites, laboratories, and clean rooms.
This is a field-based role with full responsibility for the project from planning through completion and handover.

Requirements:

  • B.Sc. in Mechanical Engineering / Biotechnology / Biomedical Engineering
  • Minimum 5 years of project management experience
  • Experience in the pharma / biotech / medical device / food industries – a must
  • Ability to work independently, with strong organization, accuracy, and cross-functional coordination skills
  • Willingness to work in the Central and Southern regions

 

The Manufacturing Engineer provides technical support to the production team.  Responsibilities include providing technical and floor support associated with safety, manufacturing and quality methods, documentation, tooling, and equipment, reduce product cost and improve product quality

 

Essential duties & responsibilities: (detailed description)

Responsibilities:

    ·    Develop manufacturing tools, fixtures, jigs and product parts and assemblies including design, documentation (including SOPs) to drive process improvements.

    ·    Support to process validation (and IQ/OQ/PQ) including writing, executing, results analysis and reporting of test protocols and reports.

    ·    Work with Production Quality to resolve manufacturing and quality problems related to methods, processes, tooling, equipment and product design.

 

Authorities:

    ·    Create engineering drawings and specifications.

    ·    Create protocols, reports, SOPs and associated documentation.

    ·    Support maintenance activities

Education & special trainings:

·        Mechanical Engineering Degree

 

 

Qualifications & experience:

  •  Hands-on – technical with experience in manufacturing/engineering environment 5-10 years, Independent in leading Projects and tasks.
  • Aware of and comply with medical device Quality Management System
  • Knowledge and understanding of document control, design transfer, verification, validation, acceptance activity, DMR, DHR.
  • Mechanical design in CAD software – SolidWorks (an advantage)
  • Proficient in English and Hebrew

 

Physical & mental requirements:

·        Physical: Sufficient dexterity to perform the tasks as listed in the job description.

·        Mental:

o   Must be self-motivated

o   Good verbal and written communication skills – must have

o   Good technical and problem-solving skills

o   A great team worker

 

Cononsulting and supporting companies in clinical trial management, building regulatory plans, clinical study planning, writing study documents, identifying suitable sites, and maintaining direct contact with physicians.

The role also includes:

  • Initiating and setting up clinical studies
  • Clinical monitoring
  • Building study teams
  • Developing CRFs
  • Writing protocols
  • Leading trainings and instructional activities
  • Working with CROs and vendors
  • Providing comprehensive client support in this area

Requirements:

  • Bachelor’s degree in a relevant field – required
  • At least 1 year of experience as a Clinical Research Coordinator or CRA – required
  • Experience in pharma / biotech / medical device – required
  • Experience in clinical trial management
  • Experience in medical devices – a significant advantage
  • Ability to work in a team, drive processes, and manage external service providers intensively
  • Experience managing independent projects – an advantage
  • Ability to support multiple projects simultaneously

Understanding the regulatory requirements in the target countries for medical devices. Interaction with Notified bodies and consulting companies in the target countries. Writing and submitting the registration documents.

Requirements:

  • Graduate of a relevant university degree- Must
  • Relevant experience in the industry – Must
  • Experience in registration in Europe / USA / Canada – an advantage
  • High-level English

Applying:

If you find that you are suitable for the job requirements, we would appreciate your sending of your resume directly to: jobs@rs-ness.com

Thank you in advance and good luck

* Appropriate inquiries will be answered

Validation testing and performing (IQ / OQ / PQ)

Writing reports and protocols, coordinating with different interfaces in the company,
supporting projects from the planning stage to execution and delivery to the customer.
Working on several projects in parallel.

Requirements:

A must –

  • A Bachelor’s degree in Mechanical Engineering / Chemistry / Biotechnology –
    3 years experience working in the pharmaceutical / biotech / medical device industry

Holds a certificate of practical engineer with relevant experience in the pharmaceutical / food industry

  • High level of English
  • Knowledge of clean rooms, HVAC systems, water systems, process equipment
  • Experience in writing procedures / work and maintenance instructions
  • Experience from a pharmaceutical / biotech / medical device company – a significant advantage

Applying:

If you find that you are suitable to the job requirements, we would appreciate your sending of your
resume directly to: jobs@rs-ness.com

Thank you in advance and good luck

* Appropriate inquiries will be answered

Position definition and requirements:

  • Defining and writing of validation documents (VP, URS)
  • Conducting acceptance tests (IQ / OQ / PQ) in collaboration with engineering,
    laboratory, production and QA personnel
  • Supporting the IT activities during deployment of the production systems and embedded computer labs at all stages (from initiation to system retirement)
  • Supporting the preparation and installation of the IT infrastructure for the deployment of the systems (communications infrastructure, hardware, users management, backups, remote connection)
  • Periodic reviews of system maintenance and compliance with regulatory requirements
  • Close and ongoing work with the engineering, production and lab personnel at the company’s plants, with the IT personnel in the company, and with external suppliers in Israel and abroad

Requirements

BA in the field of Technology, Engineering, Science

Experience in performing testing of computerized systems

3 years of experience in QA, IT at an industrial company

High level English

Working in a regulatory environment and good familiarity with regulatory requirements: GAMP5 / Part 11 / Annex 11 – A significant advantage!

 Applying:

If you find that you are suitable to the job requirements, we would appreciate your sending of your resume directly to: jobs@rs-ness.com

Thank you in advance and good luck

* Appropriate inquiries will be answered

  • B.A. in Mechanical Engineering/ Biotechnology/ Life Sciences
  • 3 years of experience with medical device Quality and Regulatory requirements (ISO13485, GMP)
  • Experience in writing and implementing Quality system comply with ISO13485
  • Experience working with R&D and Manufacturing departments
  • Familiarity with the Medical Device Directive (MDD) requirements
  • Has participated at least once in a CE quality/regulatory audit
  • High level English

Applying:

If you find that you are suitable to the job requirements, we would appreciate your sending of your resume directly to: jobs@rs-ness.com

Thank you in advance and good luck

* Appropriate inquiries will be answered

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