Staff Engineer Manufacturing

The Staff Engineer will provide technical leadership across various project related activities. A knowledge of the design, development, and validation of manufacturing technologies essential for the role. This role will focus particularly on supporting the project team in validation and SOP documentation preparation as well as change control requests.

• Provide engineering support for new equipment and process changes, ensuring that all activities are completed and documented in accordance with regulatory requirements.
• Write and edit standard operating procedures, test methods, technical/validation reports, regulatory submissions, investigations, and other related documents (VP, IQ, OQ, URS, etc.)
• Evaluate process layouts in terms of supporting new process integration while ensuring best utilisation of floor space ensuring optimum process flow.
• Support budgetary, scheduling, and project databases, and report regularly to project manager on progress as well as on problems that could significantly affect cost or schedule.
• Development of appropriate supporting documentation, SOPs, PFMEA, Control Plans and process work instructions compliant with current Good Manufacturing Practices (GMP).
• Transferring and implementing processes, either from development, or from another manufacturing facility.
• Partner with technical leadership and cross-functional partners such as Manufacturing, Quality, Process Development, Validation, and Facilities to implement appropriate written documentation.
• Work with initiators to rewrite, clarify, or reconstruct controlled documents and investigations.
• Developing specifications in the form of a URS for new equipment purchases.
• Conduct MSA studies for products and new processes.
• Responsibility as technical lead for projects (value stream and cross functional) as assigned by the company, including the scoping, approval, budgeting, specification, execution, qualification and operational handover as appropriate.
• Observing the Quality Management Systems requirements on site at all times All other duties as assigned.

• Level 8 Degree in Mechanical Engineering or equivalent technical experience is required.
• Proven Project Engineering skills through the delivery of business critical projects or equivalent.
• Minimum 4 years’ experience in a GxP manufacturing environment.
• Strong communication and influencing skills with both internal and external agents.
• Capable of working as part of a multi-disciplined team in an aggressive, dynamic and results motivated environment.
• Demonstrable analytical & problem-solving skills, a process improvement orientation, and the ability to handle multiple tasks in a fast-paced and results-oriented environment.