EMEA | SINGLE-USE ASSEMBLY LEAD

Description

This is an operations role that will also support commercial and will be focused on establishing, scaling, and supporting the Single-Use Assembly cleanroom operation at NAE Coevorden. The successful candidate will bring hands-on cleanroom operations experience, single-use assembly knowledge, and market development capability. The role will lead the strategic deployment of manufacturing technologies to the Coevorden plant based on risk and demand to support both the start-up phase and long-term growth of the EMEA single-use business.

Requirements

The primary focus of the role will be to lead and establish the NAE Coevorden Single-Use Assembly production project through cross-functional collaboration with Production, Quality, Product Development, Supply Chain, and Commercial teams across Southampton, Warrington, Coevorden, and other relevant NewAge locations.

Responsibilities will include, but are not limited to:

• Scoping out + producing the Cleanroom Operating procedures (SOPs) for Single Use Assembly operations at NAE Coevorden
• Establishing the necessary equipment requirements for the above
• Establish a particulate reduction program for continued improvement in Single-Use systems.
• Establishing an NAE Sterility Program in close collaboration and support with & from the TEAM at NAI
• Identify and implement packaging systems for primary, secondary and tertiary packaging.
• Collaborate with Quality on validation procedures specific to single-use systems.
• Establish component transfer protocols into cleanroom to mitigate particulate emissions.
• Provide training to operators on single-use manufacturing techniques.
• Collaborate with Manufacturing Engineering on molding operations for assembly manufacturing.
• Managing in totality the Single Use Assembly Project (SUAP)
• Managing and initially carrying out the production of Single Use assemblies / Manifolds in the subsequent Cleanroom operation
• Liaising & collaboration with the Supply Chain team for the ordering & storage & transfer of component parts, both in Coevorden & NAI Stateside
• Collaborating with Engineering on Design & Drawing of the initial assembly & manifold potential
• Working with the Commercial team & acquiring customer sign-off for said drawing & designs
• Overseeing & Management of the above requirements

Additionally: Market Development Expectations and Accountability

In addition to operational leadership, the successful candidate will support NewAge BV growth by helping develop and strengthen NewAge’s EMEA single-use assembly offering. As requested by Commercial, the role requires strong customer-facing skills and the ability to translate NAI’s technical capability into business growth.

Commercial and business development responsibilities include:

• Support Commercial to drive & develop revenue growth, through the construction & implementation of our cleanroom capabilities designed to meet the needs of pharmaceutical and bioprocessing.
• Building & owning the on-site EMEA specific quotation program for US intercompany approved transfer pricing, from concept to implementation
• Business development for SUAP at customer account levels, as directed by Director EMEA
• Support Commercial in building strong relationships at key EMEA SUA accounts, ensuring high service level, customer loyalty & satisfaction
• Continual cross-functional collaboration with the Global Strategic Account Team
• Assist the Director EMEA in leading customer engineering to order opportunities
• Track & report on SUAP metrics, ensuring enablement & alignment with business objectives
• Act as the VoC, advocating for their needs & ensuring timely resolution of issues