Hybrid working eligible
Scope:
This is an excellent opportunity for an experienced Process Engineer to join a global, world renowned company. The role will see leading technical aspects of projects, focusing on manufacturing technology design, development, and validation. This role is perfect for someone who has solid experience working as a Process Engineer as part of large projects and wants to grow and develop in a market leading company.
Responsibilities:
- Providing engineering support for new equipment and process changes, ensuring activities are documented per regulatory requirements.
- Writing and editing SOPs, test methods, technical/validation reports, regulatory submissions, investigations, and related documents (VP, IQ, OQ, URS, etc.).
- Evaluating process layouts to support new process integration, optimizing floor space and process flow.
- Supporting budgetary, scheduling, and project databases, reporting progress and issues affecting cost or schedule to the project manager.
- Developing supporting documentation, SOPs, PFMEA, Control Plans, and work instructions compliant with GMP.
- Transferring and implementing processes from development or other manufacturing facilities.
- Collaborating with technical leadership and cross-functional teams (Manufacturing, Quality, Engineering, Finance, Facilities) to implement written documentation.
- Developing specifications (URS) for new equipment purchases.
- Leading assigned projects, including scoping, approval, budgeting, specification, execution, qualification, and operational handover.
About You:
- Bachelor's or Master's degree in Mechanical Engineering or equivalent qualification
- Minimum of 5 years with 2 ideally being in GxP manufacturing
- Proven and solid background in project engineering skills
- Ideally Six Sigma/lean expertise demonstrated in the manufacturing, process development and validation of new products is highly desired.