Process Engineer

3 weken geleden

Leiden, Zuid-Holland, Nederland Yacht Voltijd

Bedrijfsomschrijving

About the Company

Mentor Medical Systems BV is known worldwide as a renowned manufacturer and supplier of medical products. The company's headquarters are located in Santa Barbara, California (USA). The Leiden site develops and produces high-quality products that are used in plastic surgery. Since January 2009, Mentor has been part of Johnson & Johnson.

Why YACHT ?

Because of challenging positions at leading (biotech) companies, a large network and development opportunities These are the advantages of working via YACHT.

With us, you will get all the space to grow further. Together we will look for assignments that suit your ambitions and help you to realize your goals. Through coaching, for example, but also by inviting you to interesting courses, knowledge sessions and inspiring meetings.

Through us, you will get access to a network of professionals and companies that are happy to share their knowledge and opportunities with you.

Functieomschrijving

Job Description

Yacht Life Sciences has a vacancy for a Process Engineer to work at Mentor Medical / Johnson & Johnson in Leiden.

The responsibilities of the Process Engineer:

  • Reviews and analyzes complex task statements, standards, specifications, engineering drawings and other documentation to determine engineering requirements.
  • May direct preparation of milestone charts, manpower and material estimate inputs, and related material needed to define program schedules and prepares reports, proposals and presentations. Analyzes customer technical requirements and recommends solutions beneficial to the customer and to the company's engineering and scientific reputation.
  • Responsible for assuring that the generation, release, and maintenance of documentation is in accor.
  • Designs complex mechanical, electronic and electrical assemblies and systems using typical components.
  • Provides technical expertise and assistance to assigned engineers, drafters and technicians.
  • Reviews proposed designs and test plans for conformance with task and contract requirements. Analyzes test data for accuracy and consistency.
  • May inspect, certify and evaluate on-site operational systems and establishes test plans and guides technicians in the collection of test data in a form suitable for analysis.
  • Determines appropriate test criteria and procedures and analyzes data comparing against specified and computed values, making changes and improvements where needed.
  • Plans and conducts work requiring judgment in the independent evaluation, selection and substantial adaptation and modification.

Other duties & responsibilities are:

  • Supports the introduction of New Products/Equipment.
  • Providing User Requirements (URS) to (line) Engineering
  • Identifies documentation affected (SOP's and Work Instructions);
  • Supports training for manufacturing operators in the correct use of the equipment;
  • Supports the qualification of the equipment
  • Leads a Team as part of the End to End production

Responsible for assigning operators per team:

  • Timely identification of the need for additional Asset(s).
  • Ensures the month targets are met according MPS (manufacturing Production Schedules)
  • Review and report the performance of the individual team leaders to the next management level and hold at a minimum the 5 performance conversations
  • Performs other duties assigned as needed.
  • Responsible for keeping all documentation that is necessary for the execution of the process up-to-date
  • Performs Periodic Review on his / her team.
  • Overseeing activities and tracks metrics in relation to manufacturing steps, processes, sampling and/or design validations.
  • Evaluation of the available information (i.e. Training, Non conformances, Yield and sick );
  • Report including conclusion; determining required corrections
  • Leads investigations of deviations if needed escalates to line specialist and/or line engineers.
  • Is responsible for the proper bounding and labeling according procedure
  • Ensures documentation is done in timely manner according procedure
  • Supports CAPA's and can be part of an investigation group.
  • Supports Operations in his / her area of expertise where it is expected that he / she can solve the most common problems independently
  • Sets the right priorities, where necessary in close coordination with those involved.
  • Is focused on ensuring a thorough and flawless production process to meet the highest standards
  • Builds strong and productive relationships with all different departments and layers within the Leiden site and within the J&J network.
Functie-eisen

Job requirements

  • Bachelor or Master Degree in Biochemistry, Pharmacy, Biotechnology, Science, Innovation, Engineering or equivalent
  • More than 5 years of work experience, preferably within in the Medical Device industry, medical field, or in a pharmaceutical environment
  • Experienced process engineer
  • Computer skills in relation to usage of automation software such as Excel, Windows, ERP software
  • Six sigma and process excellence tools/methodologies
  • Detailed knowledge of the manufacturing Process, end to end
  • Familiar with the CGMP requirements insofar as these relate to his / her work.
  • Familiar with the EHS & S requirements insofar as these relate to his / her work
  • Ability to identify continuous improvements in (work) processes and communicate these to line engineer
  • Ability to investigate the cause of problems and makes good use of the data. Identifies ideas and actions that focus on structural solution
Arbeidsvoorwaarden

Terms of employment:

We offer a challenging position which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development. This concerns a secondment contract for 1 year via Yacht with an assignment at Mentor Medical / J&J for at least 1 year (the permanent contract at J&J is anticipated). Salary between 3500 and 4500 euro gross per 4-week period.

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