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Title:  Sr. Validation Engineer

Requisition ID:  58103
Date:  Nov 11, 2022
Location: 

Tempe, Arizona, US

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 new product introduction (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 the Validation deliverables on selected Global Engineering 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 onsite
  • Chair, schedule, and minute validation meetings and participate in meetings when required
  • Prepare, review, and/or approve 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
  • Generating, communicating, and updating Validation document tracker
  • Manage the archiving and filing of validation documentation associated with the project, including the management of same on MasterControl
  • Lead equipment process and/or Design FMEAs
  • Leading the review and disposition of all attribute and variable data for the program against customer specification/drawing e.g. Analyzing and reporting of key measures – PPks, CPKs, 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
  • Implement best practice principles into West QMS as applicable
  • Support internal and external audits
  • Trending and tracking of Validation data to drive improvements to Sampling data, project protocols, and reports
  • Other duties as assigned

 

Basic Qualifications: 

  • Bachelor’s degree or third level qualification in Engineering, Quality, or Science related field.
  • Minimum 5 years of experience in a high-volume manufacturing environment
  • A thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 is essential
  • Must have an in-depth knowledge of validations in a Medical Device environment

 

Preferred Knowledge, Skills and Abilities:

  • Excellent understanding of plastic process manufacturing
  • Good understanding of computer system validation
  • Thorough understanding of statistics, SPC, and ideally the use of Minitab
  • Auditing experience to the requirements of ISE 13485 / 21 CFR Part 820 is preferred
  • 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
    • List any safety requirements applicable to role within your country
  • Able to comply with the company’s quality policy at all times.
    • List any quality requirements applicable to role within your country

 

Travel Requirements:

  • Must be able to travel up to 5% of the time

 

Physical & Mental Requirements:

  • Demonstrated ability to lead, influence, and train others
  • Must be able to work in a fast-paced environment
  • Must be able to organize and prioritize tasks; must be detail oriented and self-motivated
  • Must have excellent communication skills, both verbal and written
  • Must be able to prioritize and organize tasks appropriately

 

 

 

 

 

 

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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