The manufacturing support engineer role has responsibility
for providing Process Engineering and manufacturing support for the Bulk Drug
Substance manufacturing processes on site.
They will drive culture of continuous improvement and
high standards for safety, compliance, sustainability and process excellence.
The manufacturing support engineer will support the company strategic vision for multi-product manufacturing by actively working with
various NPI Project Teams to ensure that processes fit within the plant,
timelines are met, and production targets are achieved.
They will work with stakeholders in Manufacturing,
Engineering and Quality to advance process improvements to existing processes.
The role will provide tactical direction to all teams
tasked with optimizing the plant's performance and throughput.
You will be responsible for:
· Identify and implement process
optimization/process safety projects throughout the facility.
· Act as Process SME on all manufacturing
processes within the Bulk Drug Substance facility.
· Review of design / specification of equipment
and systems to ensure they meet current regulations and fit the existing BDS
· Review new Process Equipment and NPI process to
ensure they are designed with long term operability of the plant as a focal
· Review of New Product Introduction
· Design Changes to ensure there is no impact to
existing manufacturing processes.
· Liaisie with other discipline leads on process
issues and lead a team of manufacturing technologists in identifying process
· Ownership of the process-related aspects of
projects, providing technical support to the design team
· Develop relationships with all key stakeholders
within the facility (Operations, Technical Services, Engineering, Automation,
Quality) to ensure that critical projects and initiatives related to BDS
manufacturing are completed as per project charter and timelines
· Supporting Global teams in Basis of Design and
Facility Fit studies for future site capability
· Daily troubleshooting of complex manufacturing issues
with a focus on finding suitable and extensive fixes that will drive a culture
of operational excellence
- Minimum 5+ years of experience in a relevant technical
role within the BioPharma industry, with a focus on Drug Substance Process
- Excellent technical abilities with a base in engineering.
- Ability to keep work pace and meet deadlines. Good organisation
and planning skills.
- Strong leadership and communication skills. Problem
solver with a focus on achievement of overall project goals.
- Ability to work independently with minimum direct
- Experience in issue description, root cause identification,
technical/quality impact assessment & corrective action justification.
- Must be goal-oriented and able to prioritize and manage