Process Validation Engineer

Process Validation Engineer

  • Position
    Process Validation Engineer
    Swords Co Dublin, Dublin, Ireland
  • Category
    Industrial & Manufacturing
  • Organisation
    Siemens Healthcare Diagnostics Manufacturing Limited
  • Image / logo
  • Salary
    Unspecified
  • Location
    Swords Co Dublin
  • Country
    Dublin, Ireland
  • Primary Category
    Engineering
  • Type of Position
    Full-Time
  • Education Requirement
    Bachelor's degree
  • Experience Requirement
    3-5 years
  • Professional Title Requirement
    None
  • Accreditation Requirement
    Does not matter
  • Membership Requirement
    Does not matter
  • Posted
    11/01/2017

Details

Process Validation Engineer

 Permanent Role

(Science or Engineering background)

Siemens Healthcare Diagnostics Manufacturing Limited (part of Siemens Healthineers) has an opening for a Process Validation Engineer with specialization in Materials science at our site in Swords, County Dublin.

Responsibilities:

Process Validation & design change verifications

1.      Responsible for the site master validation plan and for leadership of all process validation activity on site. Active member of Validation review board.

2.      Responsible for input into design change and process change verifications in order to meet optimum regulatory and technical standard. Full time member of design change review board and deviation review board.

3.      Act as key liaison and knowledge transfer champion among Manufacturing engineering, R&D, Document control and Quality assurance in order achieve overall excellence. Ability to develop into a mentor role for the team is desirable. 

4.      As a key member of cross disciplinary engineering team you will also have the opportunity to contribute  directly to the development of engineering solutions for both product and process

Technical Writing

As a member of the site Engineering team you will specialize in compiling and reviewing technical reports to meet technical and regulatory standards of excellence.

Technical reports cover a broad range of activities, including verification, validation of product and process changes, risk assessment, technology transfer plans, equipment commissioning, deviations, corrective and preventative actions documents.

Refinement and update of internal engineering and quality system procedures in order to achieve both lean and fully compliant process.

Analytical Support

Act as key knowledge leader within the Engineering team and interface point to local 3rd level institutions and external analytical labs to analyze and diagnose material related problems using most relevant analytical technique, (e.g. SEM, FTIR, Mass Spec, X ray Plastic molding analysis etc.) 

Act as a knowledge leader in guiding internal laboratory practice in formulation of test standards and reagents for instrument testing, re-composition of standards, preparation of test reagents, correlations and equivalence.

The successful candidate will report to a Principal Engineer and will be a member of the site level Engineering Team at Swords.

 Qualifications/Skills/Experience for this role:

  • Minimum of Bachelor’s degree in relevant technical discipline (ideally Biochemistry, Chemistry, Materials Science, Microbiology, Biomedical, Engineering, Chemical Engineering.  Some potential for Physics, Mechanical, Mechatronic, Electronic Engineering with relevant experience.)

 

  • Masters or  PhD level may be  a relevant consideration.

 

  • Approx. 5 years relevant experience in a regulated environment with a core appreciation of FDA regulations.

 

  • Ability to write structured, concise, unambiguous technical English with high attention to detail.

 

  • Organisational skills, with ability to follow assignment through to completion.

 

  • Cross technology and cross discipline  collaboration skills.

 

  • Aptitude for systems level thinking, including development of  standard operating procedures.

 

  • Core understanding of scientific  and laboratory methods - including Materials analysis techniques (e.g. SEM, FTIR, Mass spec, Chromatography) and reagent formulation (laboratory practice.)

 

  • Understanding of Biochemistry, Immunology and Hematology diagnostic technologies would be an advantage.

 

  • Statistical analysis and design of experiment experience desirable.

 

  • Computer literacy (including MS Word/ Excel/ Powerpoint/ MS Project)  and Interface to Product Lifecycle tools such as SAP,  Teamcenter.

 

How to Apply / Contact

Applications to pauline.gregan@siemens.com or telephone 8132170.