Global Sr Process Engineer SME Compounding

West Pharmaceutical ServicesJersey Shore, PA
1d

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 SummaryThe Global Sr. Process Engineer SME Compounding is a member of the West Global Engineering Team. This role is key to implementing new technology, developing and introducing process improvements, standards, life cycle management and validation in select process areas, helping to advance and transform West’s growing business, supporting capital investments and contributing to addressing complex assignments. With a global mandate and scope, this person will have the opportunity to drive the implementation of new innovative processes and technologies in cooperation with the engineering and quality assurance teams and the plants.  

Requirements

  • Bachelor's Degree or Master's Degree (preferred but not required) in Engineering or Working on a Degree and Equivalent Experience required
  • Fluent in English
  • Proficient in Microsoft based programs
  • Minimum 5 years of experience in Manufacturing Environment required
  • Excellent Interpersonal skills: good team player and individual contributor as well Ability of authoring / revising SOI, SOP’s, and validation documents.
  • Good knowledge of LEAN and 6 sigma manufacturing principles: minimum 6 Sigma Green belt.
  • Working knowledge of SPC and Minitab software.
  • cGMP knowledge.
  • Ability of authoring / revising SOI, SOP’s, and validation documents.
  • Able to be aware of all relevant SOPs as per Company policy as they are. related to the position covered by this Job Description.
  • Good communication and interpersonal skills.
  • Good organizational skills.
  • Effective problem-solving skills.
  • Highly analytical and structured way of working.
  • Ability/courage to successfully communicate with any required parties.
  • Able to always comply with the company’s safety policy.
  • Must be able to build strong relationships with peers and direct labor employees.
  • While performing the duties of this job on the production floor, the employee regularly stands, walks, talks, and hears.
  • Noise level in the work environment while on the production floor is usually moderate to loud. Hearing protection is required.
  • Must be self-motivated, must have excellent people skills, written and verbal communication, problem solving, coaching, training, relationship building, managing resistance and project management skills.
  • Must follow and comply with all Company and Plant policies, procedure (SOIs), rules and State and Federal laws

Nice To Haves

  • Experience in Biotechnology / Pharmaceutical Manufacturing.

Responsibilities

  • Take responsibility for a well-defined process area and process related projects – here the process area in focus is Compounding.
  • Initiate, lead and coordinate continuous process improvement on quality, service, HSE and cost within the standard known/approved process frame and using best practice knowledge.
  • Provide expertise in Compounding technologies relevant for West products within Global Engineering and to other West functions. Acquire further knowledge in Compounding technologies.
  • Support the introduction, start-up and validation of new equipment in the plants.
  • Lead workstreams to implement / roll-out new innovative processes and technologies in cooperation with the engineering- and QA team and the plants.
  • Manage the development of robust processes for final industrial production in targeted plants.
  • Assess the current Compounding process status in all relevant West locations globally, define best practices, perform a gap analysis and manage the harmonization of this best practice to all plants involved.
  • Prepare and obtain approval for project time schedules and ensure conformance to such plans and to the related budgets in implementation.
  • Initiate and maintain appropriate communication with facilities and departments in order to support good relations and maximise achievements through a cooperative environment.
  • Manage product, process or technology transfer projects between plants from a process stand-point as assigned.
  • Engage in solutioning product or process related issues as needed.
  • Utilize six sigma tools in minimizing process variations and improving the quality of West’s products.
  • Ensure that all projects and activities are in compliance with local, regional and best practice requirements on HSE and meet other applicable authority requirements.
  • Support the implementation and maintenance of a system to gather operational knowledge (Knowledge Management).
  • Coordinate interface between the West Digital & Transformation Team (“D&T”) and the shop-floor production for new products.
  • Participate in budgeting and business planning activities.
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