General Information

Job Advert Title
Graduate Validation Engineer
Location
Ireland
Function/Business Area
Manufacturing
Department
Tralee Plant
Employment Class
Intern/Student/Trainee (I)

Description

Graduate Validation Engineer

About Astellas:

At Astellas we are a progressive health partner, delivering value and outcomes where needed.

We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. 

Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. 

We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes. 

Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.  

The Opportunity:

As a Graduate Valuation Engineer, you will be responsible for reviewing, developing, and controlling validation activities for all company projects. Preparing validation documentation and reports. Executing validation protocols. Working with personnel in implementing the validation lifecycle for projects.

You will be part of an inclusive team that works to develop innovative therapies for patients.

Key Activities for this role:

  • Validation Scheduling
  • Evaluation of validation requirements.
  • Provide support to ensure that validation status reports are maintained.
  • Validation Standards
  • Familiarisation with developments and innovations in validation requirements.
  • Review/Implementation of procedures, reports, results etc. for compliance.
  • Validation Preparation Execution and Approvals
  • Execution of validation Protocols.
  • General
  • Provide input into the development of company validation standards.

Essential Knowledge & Experience:

  • Knowledge and understanding of Aseptic Manufacturing techniques Knowledge of ISPE baseline Guide for Commissioning and Qualification Understanding of pharmaceutical quality management systems, experience of various QMS tools such as Track Wise, Valgenesis, Vault. Proficient knowledge and understanding of regional Good Manufacturing Practices for pharmaceutical products.
  • Actively participating in the investigation and resolution of quality events.
  • Conducting internal audits and supporting external regulatory inspections.
  • Reviewing and approving documentation related to manufacturing processes and quality systems.
  • Providing guidance and training to colleagues on quality-related matters.
  • Continuously monitoring and improving quality systems and processes.

Education/Qualifications:

  • Bachelor’s degree in engineering or equivalent.

Additional Information:

  • Type of role 2 years fixed term contract.
  • Location Irish office (Kerry plant).
  • This position is field based.

What We Offer:

  • A challenging and diversified job in an international setting.
  • Opportunity and support for continuous development.
  • Inspiring work climate.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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