The purpose of the role is to provide process engineering support to Sterile Fill Finish Drug Product, in the design, commissioning and qualification of equipment and processes.
The purpose of the role is to provide process engineering support to Sterile Fill Finish Drug Product, in the design, commissioning and qualification of equipment and processes to facilitate the manufacture of development, clinical and commercial existing products.
Qualifications and Skills Required
* Qualified to a minimum of Degree level in engineering or related discipline
* Minimum 8 years of Process Engineering / Technical Services experience within a relevant Pharma. environment (preferably within a sterile manufacturing environment)
Skills and Behavioral Competencies Skills
* cGMP compliance
* Capable of developing and implementing solutions to complex problems within a team dynamic using proven problem solving techniques
* Ability to understand engineering processes through a logical, data driven, hands on approach
* Use of FMEA, FMECA and Risk assessment techniques
* Can interact with audits (internal and external) providing technical assurance from a quality and safety perspective
* Strong report writing skills
* Focus on people and process.
* Motivating others positively
* Ability to work independently and in teams
* Natural influencer
* Be driven by task / project and will show flexibility to ensure results are achieved.
* Self-starter and accustomed to setting personal goals
Morgan McKinley are working in partnership with Horizon Therapeutics.