Manufacturing Process Engineer

Team Horizon is seeking a Manufacturing Process Engineer in Mayo for our client who are a global leader in the biopharmaceutical industry. In the role, you will have the opportunity to optimize and improve the efficiency of manufacturing processes within a multi-product aseptic environment across a wide range of process and equipment types. You will be required to ensure efficient operation of aseptic Filling lines and associated equipment. In this role you will become a ‘Subject Matter Expert’ across critical aseptic processes and will identify and lead the implementation of process improvement projects. The position will require dealing with challenging technical problems within a highly regulated environment. The successful candidate will have the ability to co-ordinate with multiple stakeholders and varying levels and areas of expertise, ensuring that the necessary skill sets for successful project delivery are available. 
 
Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.


• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.


• Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.

 
What you will be doing:

• Provide technical assistance to the manufacturing areas relating to the process and equipment to address issues and exceptions or support improvements.


• Develop and implement changes that will enhance equipment performance, product quality, reduce manufacturing costs and maximise efficiencies.


• Develop and modify procedures as needed to support the manufacturing areas. Submit Change plans and create investigation reports.


• Support the transfer of new products to the manufacturing area.


• Participate in process, equipment and facilities validation efforts and project implementation.


• Maintain manufacturing area equipment in compliance with site calibration and maintenance program.


• Provide support to Technical Shift Leads on batch records.


• Provide assistance and present when required at Regulatory Inspections.


• Comply with company policies and procedures and regulatory agency regulations.


• Evaluation and implement new equipment and process technology.


• Initiate capital project ideas dealing with safety, quality improvements, increases in capacity and/or cost reduction.


• Any other duties as assigned.

 
What you need to apply:

• Bachelor’s degree in Chemical, Mechanical Engineering, or a related discipline is required.


• A minimum of 2 years’ experience in process / equipment engineering in a manufacturing environment of biotechnology, pharmaceutical plant desired.


• Lean Six Sigma/ Continuous Improvement experience is desirable.


• Detailed knowledge of CGMP and regulatory requirements relating to the pharmaceutical industry is required for this role.


• Possess strong technical knowledge and application of concepts, practices, and procedures.


• Good interpersonal skills to develop working relationships with people at all levels.


• Ability to lead projects.


• Ability to quicky adopt to changing business / project demands.