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Title:  Snr Engineer, Software Validation Testing

Requisition ID:  46512
Date:  Aug 4, 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 be responsible for leading the industrialization and manufacturing software validation development and testing by supporting the West Proprietary and Contract Manufacturing business in the design transfer of drug delivery devices into production by participating in design, build, commissioning and qualification of new and existing equipment with key focus around leading test method software validation of mechanical and electromechanical test fixtures with an emphasis on DFM.

 

Essential Duties and Responsibilities:

  • Lead industrialization and manufacturing software testing development and implementation for components and finished product such as PCBA, battery, motor and electromechanical systems.
  • Interpret product design requirements to develop specific test methods in accordance with product specification requirements.
  • Participate in product design and engineering reviews as required.
  • Prepare and execute applicable software test method validation protocols, reports and applicable SOP generation; including measurement system analysis (e.g. gage R&R and equivalency studies).
  • Lead Software Test Validation Strategy including Validation V model requirements - URS, RTM etc. change management documentation and source code review in conjunction with vendor, customer and internal SME teams.
  • Perform all necessary scientific and/or engineering studies; calculations: such as component second or components end of life source selection, performance analysis, voltage, frequency and temperature analysis as required.
  • Collaborate with production vendors, internal customers including engineering SME’s to define and solve manufacturing/design issues and implement cost reduction measures including assessments of existing and new supplier capabilities.
  • Collaborate with design engineering team on alignment of design development and verification production and testing with that of production.
  • Conduct risk analysis and develop risk mitigation actions for manufacturing related issues, problems or improvements.
  • Interface with Operations and Quality department to support transfer and sustainment of test methods including failure investigations, deviations, change control, and continuous improvement.
  • Direct the integration of technical activities and products into manufacturing. Evaluate and approve design changes, specifications, and schematics. Maintain specification and operational documentation as required.
  • Update project related data as required in applicable systems and ensure timely reporting and response to stakeholders.
  • Fosters and encourages shared learning’s across Global Device Engineering e.g. system and technology best practices.
  • Review and approval of third party generated protocols and reports in conjunction with program Quality representation.
  • Drive solutions, in conjunction with the appropriate department, to ensure customer related testing problems are communicated and corrective actions are in place and closed in a timely manner.
  • Support internal and supplier audits where required.
  • Assist with the training and development of personnel at all levels of West on new processes or systems introduced to the company.
  • Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
  • Perform additional duties at the request of the direct supervisor.

 

Basic Qualifications: 

  • Bachelor’s degree (US) or third level qualification (EU), at a minimum to degree level, in Computer Science, Engineering or related fields.
  • Must have 5 years of software validation testing experience with Manual and Automated testing incl software validation standards.
  • 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:

  • Strong experience in developing software test methods for medical device products including PCBA’s, electromechanical, battery and motor (OrCAD /Altium Designer preferred).
  • Experience in the execution of commissioning and qualification of process control systems (e.g. Delta V), PLC and SCADA systems and Enterprise systems preferred.
  • Vendor management experienced including project management skills.
  • Firmware programming experience is a plus.
  • A thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820, 21 CFR Part 11, FDA Design Controls and Statistical methods is essential.
  • Must have an in-depth knowledge of software validations in a Medical Device environment.
  • 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 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 orientated and self-motivated.
  • Must have excellent communication skills both oral and written.

 

 

 

 

 

 

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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