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Product Engineer / Process Validation Scientist - Pharmaceuticals in Leicestershire

Product Engineer / Process Validation Scientist - Pharmaceuticals

Leicestershire

Our client is a global technology company which manufactures and packages pharmaceutical and medical products in various dosage forms at its site in Leicestershire. Due to continued strong growth they are currently looking for a new Product Engineer to join the Manufacturing Technology Department.

In this role you will be working as part of a technical team focused on product understanding and improvement. Key duties will include developing product understanding, writing and managing technical documentation, reviewing product performance and taking ownership of process validation for a range of Pharmaceutical products. You will interact with internal manufacturing, logistics and technical colleagues and possibly with external customers and suppliers.

Job Responsibilities

  • Provide ongoing technical support for a specific product family, including writing batch manufacturing records, writing manufacturing production recipes and relevant documentation updates.
  • Leadership of annual Product Quality Reviews including analysis of product performance data, presentation of information and completion of improvements identified.
  • Involvement in the broader technical activities of the Technology Team to ensure technical development and improvement of manufacturing processes.
  • Leadership of root cause investigations and reviewing potential quality impact for product family.
  • Prepare and execute process validation documents.
  • Understanding of product unit cost and identify improvements to reduce costs.
  • Further develop product and process understanding for the manufacturing processes.

Qualifications and experience

  • Degree or equivalent in a relevant science or engineering discipline.
  • Relevant work experience within either the pharmaceutical or medical devices industry.
  • Data analysis and subsequent technical review and interpretation of statistics.
  • Experience of GMP within a contract manufacturing environment for Medical Devices or Pharmaceuticals.
  • Lean Six Sigma Green Belt trained is desirable.
  • Process validation experience is desirable.
  • Introduction of new equipment and processes.
  • Knowledge of Medical Device and Drug Product Quality Systems such as GMP, FDA, ISO13485, Orange Guide etc. is desirable.

Personality

  • Highly motivated with the drive & energy to lead and influence change.
  • Good team player able to work with & influence others.
  • Ability to prioritise effectively.
  • Strong Communication skills.
  • Very good organisational skills.
  • Highly enthusiastic with aspirations to grow, learn and develop.
  • Confident and ambitious.

Closing date for applications is Friday 3rd August 2018

Reference

SH-PVS

Location

Leicestershire
Loughborough area

Salary

£35,000 to £50,000
Competitive salary plus benefits

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