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Title:  Sr. Eng. Validation

Requisition ID:  37921
Date:  Oct 8, 2021
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.

 

Job Summary:

In this role, you will support NPI projects with key focus around customer specification, Validation Master Plan, protocols and reports. This person will provide the company with the technical and validation resource to manage validation deliverables on selected NPI projects and will coordinate the necessary activities for ensuring the timely closure of validation activities on projects.

 

Essential Duties and Responsibilities:

  • Support the validation effort for all Strategic Projects on-site.
  • Fosters and encourages shared best practices for systems and technology across Global Device Engineering.
  • Leads and/or attends validation meetings when required
  • Perform periodic reviews of systems in order to maintain validation status
  • Develop and implement site validation strategy to meet customer and West needs.
  • Lead the preparation, review and or approval of qualification and/or validation documentation (VMPs, specifications, protocols, reports etc.) in relation to instrument, equipment, facilities, utilities, automated systems, manufacturing processes and cleaning processes including FAT, SAT, IQ, OQ, PQ phases in conjunction with program Quality representation
  • Review and approve third party generated protocols and reports in conjunction with program Quality representation.
  • Generate, communicate and update Validation document tracker.
  • Manage the archiving and filing of validation documentation associated with the project, including the management of same in MasterControl.
  • Lead equipment process and/or Design FMEAs.
  • Leads the review and disposition of all attribute and variable data for the program against customer specification / drawing e.g. Analysing and reporting of key measures eg. Ppk's, Cpk's, FOT/FAT visual inspections.
  • Drive solutions, in conjunction with the appropriate department, to ensure customer related validation problems are communicated and corrective actions are in place and closed in a timely manner.
  • Lead data presentations and attend review meetings with the customer.
  • Trending and tracking of Validation data (Sampling data, project protocols and reports) to drive improvements.
  • Other duties as assigned

 

Basic Qualifications: 

  • Candidates for European role must have a Third Level Qualification, to at least degree level, in Engineering, Quality, or, Science.
  • Candidates for North American role should have a Bachelor’s degree in Engineering, Quality, or, Science.
  • Must have a minimum of 5 years’ post graduate experience of working in a high-volume manufacturing environment ideally in the Medical Device / Pharmaceutical sector.

 

Preferred Knowledge, Skills and Abilities:

  • Implement best practices principles into West QMS as applicable.  
  • Support internal and supplier audits.
  • Assist with the training and development of personnel at all levels of West on new processes or systems introduced to the company.
  • A thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 is essential.
  • Possess an excellent understanding of plastic process manufacturing and validations in a Medical Device environment
  • Good understanding of computer system validation.
  • Must have a thorough understanding of statistics, SPC, ideally via use of Minitab.
  • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
  • Support and contribute in Lean Sigma programs and activities towards delivery of the set target
  • Able to comply with the company’s safety policy at all times
  • Able to comply with the company’s quality policy at all times.

 

Travel Requirements:

  • Must be able to travel up to 10% of the time

 

Physical & Mental Requirements:

  • Ability to learn, understand, and remember normal tasks.
  • Ability to hear, speak, read, and understand conversation in English in a normal tone of voice.
  • Must maintain the ability to work well with others in a variety of situations.
  • Must be able to multi-task, work under time constraints, problem solve, and prioritize.
  • Must also be able to maintain confidentiality and resolve conflicts.
  • Ability to make independent and sound judgments.
  • Read and interpret data, information and documents
  • Analyze and solve problems
  • Use advanced arithmetic reasoning and statistical analysis
  • Observe and interpret situations
  • Ability to lead, influence, and train others.
  • Work under deadlines with constant interruptions

 

 

 

 

 

 

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 kimberley.eby@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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