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Title:  Validation Technician

Requisition ID:  50857
Date:  Aug 6, 2022
Location: 

Dublin, Leinster, IE

Department:  Engineering
Description: 

 

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

Summary: 

Assist and support the validation team within Tech Group Europe. To sample, review and analyse the metrology data and provide feedback to the validation team on a regular basis. Assist in Batch Documentation release, scrap reporting and sign off. Provide support and assistance in creating and drafting validation protocols and reports where required. Reports to and provides support to the Process Engineer during the validation execution.

 

                         

Requirements:

  • Third level qualification in Quality/Mechanical/Plastic Engineering preferred.
  • Relevant industrial experience in a high volume injection-moulding environment would be an advantage.
  • Working Knowledge of Regulatory requirements with regard to Medical Devices and/or Pharmaceuticals.
  • Experience of using statistical techniques for Data Analysis (preferably using Minitab).
  • Must have a very good knowledge of computer systems; integrated manufacturing systems; word processing and spreadsheets
  • Must have excellent written and verbal communication skills as well as the ability to accurately document work performed.
  • Must be able to work in a fast paced environment.
  • Must be able to travel if required.
  • Must be able to organize and prioritize tasks; must be detail orientated and self-motivated.

 

 

Essential Duties and Responsibilities:

  • Quality measurement and inspection of OQ and PQ samples.
  • Complete documentation for OQ and PQ runs and assist the Process Engineer in the setup and execution of all validation activities.
  • Metrology feedback and update to validation team.
  • Support Process Engineers in validation activities.
  • Will be required to assist in preparing IQ, OQ and PQ protocols and reports.
  • Compliance to all site Environmental, Health and Safety requirements, training and regulations.
  • Compliance to all local site company policies, procedures and corporate policies.
  • Perform additional duties at the request of the direct supervisor.
  • Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.

 

 

Delegation of Duties:

 

When absent from the site duties and responsibilities will be delegated to the following designates

  •  

Process Engineer.____________________

 

 

 

 

 

 

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

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