Senior Project Engineer, Manufacturing

• 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 2 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.

Stryker