Global Sr Process Engineer SME Compounding

Overview

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 II. 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?

The 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.

The Global Sr. Process Engineer SME will be based at the West plant in either Jersey Shore, PA or in Kinston, NC.

• 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 work streams 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.

• Bachelor’s Degree or Master’s Degree (preferred but not required) in Engineering or equivalent experience required.
• Fluent in English.
• Proficient in Microsoft based programs.

• Minimum 5 years of experience in a manufacturing environment required.

• Excellent interpersonal skills: good team player and individual contributor.
• Knowledge of LEAN and 6 sigma manufacturing principles: minimum 6 Sigma Green belt.
• Working knowledge of SPC and Minitab software.
• cGMP knowledge.
• Experience in biotechnology / pharmaceutical manufacturing.
• Good communication, organizational and problem‑solving skills.
• Highly analytical and structured way of working.
• Ability to author and revise SOPs, SOIs, and…