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Job Details

Sterilisation Validation Engineer

Company: Thornshaw Recruitment
Location: Co.Offaly, Republic of Ireland
Reference: LD9713
Closing Date: 23 Mar 18
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

Our client, a medical devices company in the Midlands are currently recruiting for a Sterilisation Validation Engineer.

Requirements:

Our client, a medical devices company in the Midlands are currently recruiting for a Sterilisation Validation Engineer.

ROLE ACCOUNTABILITIES
The Sterilisation Validation Engineer will be responsible for completing validation activities associated with EO Sterilisation compliance to ISO11135:2014 and sterilisation and microbiological activities related to product changes. 

 Key duties will include but will not be limited to:

  • Complete sterilisation validations/annual revalidations in accordance with ISO11135, including protocol and report writing, validation planning, execution and result evaluation.
  • Support sterilisation/microbiology projects including cycle development, optimisation and new/revised equipment validation 
  • upport Engineering to ensure new products and product changes are adequately evaluated/tested with respect to sterilisation, bioburden, residual and biocompatibility requirements ensuring compliance with related regulatory standards
    o    Evaluate product changes to determine the level of testing required
    o    Liaise with engineers to determine test requirements and obtain test samples
    o    Liaise with test laboratories to solicit testing and  receipt of test reports 
    o    Ensure all required testing is completed in a timely manner to meet project timelines
  • Adhere strictly to company policies and procedures as notified
  • Assist in the maintenance of a safe company culture by working within the company’s environmental, health and safety guidelines at all times and reporting any equipment or process problems in line with plant escalation procedures
  • Identify continuous improvements opportunities where possible and take part in improvement projects as assigned
  • Adhere to GMP based Quality Systems requirements for medical devices and medicinal product (e.g. MDD, EU GMP Guidelines Vol IV Part 1 for medicinal product, ISO 13485).
  • Carry out additional duties that may be assigned.

QUALIFICATIONS

  • A degree in Science, Engineering or Quality related discipline.
  • A minimum of 3 years working within a regulated industry, preferably Medical Devices
  • Experience with sterilisation, quality engineering and/or microbiological activities would be advantageous
  • Experience of compliance with ISO11135, ISO10993-1, ISO10993-7, ISO11737, ISO14644 and ISO14698 would be advantageous
  • Strong communication and technical writing skills
  • High attention to detail in all aspects of the role.
  • Ability to work with cross-functional teams, including engineering, production, quality and materials. 

If you are interested in applying for this role please call Linda on +353 1 2784671 or email ldunne@thornshaw.com 
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com

Apply for this job: Sterilisation Validation Engineer

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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