Sr Specialist, Operations Engineer

West Pharmaceutical ServicesKinston, NC
71d

About The Position

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future? There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts. Job SummaryIn this role, you will be responsible for managing operations related to CAPA’s, deviation reports and out of specification reports along with leading operational excellence initiatives supporting operations to include performance trending and analysis, LDMS implantation/adherence and standard work development.

Requirements

  • Bachelor's Degree in Engineering or another scientific area preferred or
  • Minimum 5 years of equivalent experience in a similar position within the manufacturing industry
  • Minimum 5 years experience in a similar position within the manufacturing industry required
  • Fluent in English Required
  • Exhibits regular, reliable, punctual, and predictable attendance
  • Able to be aware of all relevant SOPs as per Company policy
  • Able to comply with the company's safety and quality policies at all times
  • 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.
  • Use written and oral communication skills
  • Read and interpret data, information, and documents
  • Analyze and solve problems
  • Use simple arithmetic reasoning
  • Observe and interpret situations
  • Learn and apply new information or new skills
  • Work under deadlines with constant interruptions

Nice To Haves

  • Experience in Project management preferred
  • Knowledge of statistical tools and Minitab
  • SAP Experience
  • Master Control Experience
  • Good knowledge of LEAN and 6 sigma manufacturing principles
  • Proficient in Microsoft based products
  • cGMP knowledge

Responsibilities

  • Manage CAPA’s related to Operations
  • Manage, track and complete investigations of DR’s & OOS’s specific to Operations
  • Identifies, recommends, and implements measures to improve process, quality and efficiency
  • Leads the tracking, trending, and analyzing of operations-related performance data to identify abnormalities and communicate them to the operations teams
  • Assist with learning and development in leading Operations specific training across shifts
  • Interact with production, maintenance, and engineering teams to understand and determine solutions to issues with the equipment or processes.
  • Updates, files, and distributes Operations related procedures, documentation, and validations
  • Prepare reports as may be required on a routine basis or on demand within established deadlines.
  • Participate in other duties as assigned
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