EMEA | SINGLE-USE ASSEMBLY LEAD
About the Role
This is an operations role that will also support commercial efforts, 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.
Responsibilities
- Scope out and produce Cleanroom Operating procedures (SOPs) for Single-Use Assembly operations at NAE Coevorden.
- Establish the necessary equipment requirements for cleanroom operations.
- Develop a particulate reduction program for continued improvement in Single-Use systems.
- Establish an NAE Sterility Program in close collaboration with 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 the cleanroom to mitigate particulate emissions.
- Provide training to operators on single-use manufacturing techniques.
- Collaborate with Manufacturing Engineering on molding operations for assembly manufacturing.
- Manage the Single Use Assembly Project (SUAP) in its entirety.
- Initially carry out and manage the production of Single-Use assemblies/Manifolds in the cleanroom operation.
- Liaise and collaborate with the Supply Chain team for ordering, storage, and transfer of component parts in Coevorden and NAI Stateside.
- Collaborate with Engineering on the design and drawing of initial assemblies and manifolds.
- Work with the Commercial team to acquire customer sign-off for drawings and designs.
- Oversee and manage the above requirements.
Market Development & Commercial Responsibilities
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. The role requires strong customer-facing skills and the ability to translate NAI’s technical capability into business growth.
- Support Commercial to drive and develop revenue growth through the construction and implementation of cleanroom capabilities designed to meet the needs of pharmaceutical and bioprocessing.
- Build and own the on-site EMEA-specific quotation program for US intercompany-approved transfer pricing, from concept to implementation.
- Engage in business development for SUAP at customer account levels, as directed by the Director EMEA.
- Support Commercial in building strong relationships at key EMEA SUA accounts, ensuring high service levels, customer loyalty, and satisfaction.
- Collaborate continually with the Global Strategic Account Team.
- Assist the Director EMEA in leading customer engineering-to-order opportunities.
- Track and report on SUAP metrics, ensuring enablement and alignment with business objectives.
- Act as the Voice of the Customer (VoC), advocating for their needs and ensuring timely resolution of issues.
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.