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Title:  Principal Project Engineer, R&D

Requisition ID:  58382
Date:  Nov 17, 2022
Location: 

Scottsdale, Arizona, US

Department:  R&D
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:

The Principal Project Engineer role is expected to perform with independence and is primarily responsible for configuration management and management of workstreams within R&D projects associated with West’s portfolio of combination products. Work collaboratively with cross functional teams to coordinate the work stream elements including change control, configuration management, DHF control and improvement of configuration control processes. Formulate, plan and execute completion of projects in conjunction with technical leads to targeted timelines in a manner compliant to applicable governance policies and procedures. Demonstrate creative skills in a dynamic environment along with a problem-solving leadership attitude. Development of multi-disciplinary combination product internally to West and externally with West customers.

 

Essential Duties and Responsibilities:

  • Independently analyze, plan and track project phases and activities, and communicate strategic direction regarding timelines/milestones/risks/goals on a regular basis to the leadership team and key stakeholders
  • Consistently and proactively communicate with R&D, Operations and Quality representatives and other functions to develop detailed project plans and timelines, to meet clients’ needs, and to achieve project milestones and project success
  • Review and analyze project data and information to provide status updates, insights, conclusions and strategize actionable recommendations. 
  • Implements and enables processes for consistent issue escalation and resolution
  • Challenge processes, remain open to ideas and changes to continuously improve and seek better alternatives and drive change.
  • Leads tasks with high resource requirements, risk, and/or complexity
  • Manage cross-project and program dependencies, escalating to the R&D management as needed.
  • Manage DHF documents and control activities
  • Accountable for Configuration management processes including aspects of document control, change control (ECO) maintenance, action items implementation and follow up.
  • Super user and strong knowledge of Master Control SW tool. Manage Internal SOPs using, using Master Control SW tool as a super user BOM Bill of materials configuration management for existing and new NPI product.
  • CCB (Change control board) chairman lead for R&D lead changes of the existing products.
  • Maintenance of external documents files, such as customers specifications and vendors data sheets.
  • Support SAP part number creation as required by R&D activities
  • Responsible for making Improvements to configuration control tools and process.
  • Specification generation and routing
  • Close collaboration with cross functional team members on specification content
  • Accountable for making procedure updates and generating protocols and reports
  • Effectively Facilitate meetings to align the team on requirements for documents being created/updated
  • Manage core team meetings and prompt feedback on status of open tasks
  • Define, drive and strategically manage change management and communications activities that support assigned programs.
  • Build and maintain strong relationships with customers, business partners, functional managers, and other senior level executives.
  • Solves complex problems with broad business impact.
  • Performs other duties as assigned based on business needs.
  • Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
  • Exhibits regular, reliable, punctual and predictable attendance

The job descriptions reflect the general details considered necessary to describe the principal functions of the job identified and shall not necessarily be construed as a detailed description of all of the work requirements that may be inherent in the job.

 

Basic Qualifications: 

  • Education: Bachelor’s
  • BS in Engineering
  • Experience: 10+ years
  • Engineering experience with matrix and cross-functional project teams.
  • Proven ability to lead projects in a cross-functional team environment 
  • Knowledge of combination product and medical device design control process and management of R&D support systems
  • Experience in regulated combination product and medical device development
  •  Expertise with managing resource requirements 
  •  Excellent interpersonal, communication and organizational skills with a proven record of working with and influencing multi-disciplinary teams and external experts.
  • Possesses technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).  
  • Strong negotiation and decision-making skills
  • Excellent written and verbal communication, organizational, timeline management and leadership skill
  • Self-motivated with a proactive attitude and the ability to work effectively
  • Experience in Medical Materials, Medical Device and/or Drug Delivery Systems product development preferred.  Working knowledge of applicable federal and international regulations such as 21CFR Parts 210, 211, and 820.  cGMP manufacturing experience preferred. 
  • Proficient with Microsoft Office suite software, project management software such as MS Project.

Direct/Indirect Reports: None

Preferred Knowledge, Skills and Abilities:

  • Knowledge and demonstrated experience executing projects in the medical device and pharma manufacturing industries, knowledge of applicable federal and international regulations.
  • Experience and capability at delivering written and verbal reports to senior and executive management.
  • Demonstrated ability to manage multiple globally dispersed individuals and disciplines. Must possess the ability to influence others without direct authority.
  • Requires specialized depth and breadth of expertise in industry, Program Management, and business acumen.
  • Works independently, with guidance only in complex situations.
  • Cultivates teamwork through leadership and fills knowledge/skill gaps on project teams as needed.
  • Communicates complex concepts; anticipates potential objections and influences others to adopt a different point of view
  • Interprets internal/external business challenges and recommends best practices to improve products, processes or services

Travel Requirements:

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

 

 

 

 

 

 

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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