Process Engineer (Pharma)

Leading pharmaceutical company is seeking an experienced Process Engineer to join their team on a 12-month contract. This role is based in Limerick.

Job responsibilities:

• Responsibility for the development and execution of plans to continuously improve and optimize product quality and process yield.
• Responsible for identification and implementation of process related continuous improvement activities to improve product quality and increase Overall Equipment Effectiveness.
• Ensure all process developments and improvements meet the Quality Management System requirements (ISO 13485, FDA & JPAL).
• Project Management Accurate planning, timely delivery and reporting for all project deliverables. Participate in risk assessments and HAZOPs of manufacturing processes and equipment.

Job requirements:

• Level 8 degree in Process, Production, Manufacturing, Polymer, Materials, Biomedical or Mechanical Engineering
• Minimum 4 years relevant experience with statistical process control and capability analysis required
• Familiarity with manufacturing and validation in a regulated (FDA or IMB) environment an advantage.
• Must be flexible and able to manage multiple priorities simultaneously. Experience of lean concepts such as 5S and standard work would be an advantage

If you would like to discuss this position, please reach out to Louise Whitty on 021 2359140 /

lwhitty@sigmar.ie

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

Headcount Solutions is seeking a Supplier Engineer for a client’s Medical Device manufacturing facility. This person will manage suppliers and supplier changes, from an engineering perspective, and to lead opportunities for the reduction of cost, yield or quality improvements with existing or new vendors.

Main Responsibilities:

• Liaise with Sustaining Engineering, and other departments, to develop and introduce new products, components and processes in key supplier sites.
• In conjunction with Sustaining Engineering and Supplier Quality engineering, support and advise suppliers on validation requirements as necessary.
• Work with internal groups to review and assess the impact of supplier change requests, and responsibility for implementation and approval of same.
• Support the assessment of non-conforming raw materials received from suppliers.
• Liaise with Purchasing and Supplier Quality Engineering to improve the Quality Systems procedures relating to suppliers.
• Identify and capitalise on opportunities for the reduction of cost, yield or quality improvements with existing or new vendors, via process improvement or transfer.
• Assess current internal supplier processes to streamline and optimise.
• Liaise with the Purchasing group to identify new suppliers as needed.
• Liaise with Supplier Quality Engineering and Sustaining Engineering (CAPA) to ensure the effective completion of Supplier Corrective Actions (SCA’s)
• Collaborate with Purchasing and Legal to ensure the development and implementation of effective supply agreements with suppliers.
• Ensure effective reporting to the Engineering Management team.
• Provide technical support and input when required to the Suppler Audit process.
• Responsible for operating general internal quality systems and documentation.

Requirements:

• Formal Production/Engineering qualification and relevant experience in as least one of the following areas: Manufacturing, Engineering/Device Design & Development/CAPA.
• Strong interpersonal skills and the ability to communicate at all levels of the organisation.
• Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.
• Proven Project Management and problem-solving skills.

For further information please contact Mick on 086-0435195 or forward details in confidence to jobs@headcount.ie

This well established medical devices brand with a reputation for validation is hiring a Senior Industrial Engineer for their team.

Responsible for driving operational excellence through the manufacturing and business environments through the designing, and implementing of systems to meet all key performance indicators. This requires working and influencing cross-functionally and globally.

 Job Responsibilities:

• Leading and championing major CI initiatives across the site.
• Nurturing commitment to the vision, mission, objectives, and values of the company.
• Shaping, developing, and aligning the strategies of the Operational Excellence team 
• Coaching functional and production leaders on the principles of lean & Operational Excellence.
• Leading site Kaizen events to achieve financial or strategic objectives
• Holding detailed knowledge and can teach others on all Lean tools
• Proven track record in Project Management and delivery of results
• Driving changes with the Product design and engineering teams. 
• Driving the operational Excellence strategy on-site, developing and driving new strategy, systems and tools. 

Job Requirements:

• Bachelors Degree or Masters in Lean / Operational Excellence (Level 8 minimum)
• Previous experience in a similar role within a highly regulated environment
• 6 Sigma green or black belt

For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 / marcel at sigmar.ie

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

Overview

The primary function of this position is to manage Cook Ireland’s process engineering requirements with respect to suppliers and supplier changes, and to lead opportunities for the reduction of cost, yield or quality improvements with existing or new suppliers.

Reporting to: Senior Sustaining Engineer  

Find out more about Cook Medical here

Responsibilities

• Liaise with Sustaining Engineering, and other departments, to develop and introduce new products, components and processes in key supplier sites.
• Lead process engineering projects to implement supplier based changes, from feasibility through to, validation, qualification and implementation.
• In conjunction with Sustaining Engineering and Supplier Quality engineering, support and advise suppliers on validation requirements as necessary.
• Work with internal groups to review and assess the impact of supplier change requests, and responsibility for implementation and approval of same. Become a Subject Matter Expert (SME) of Cook Ireland’s supplier processes.
• Establish and develop good working relationships with Cook Ireland suppliers.
• Support the assessment of non-conforming raw materials received from suppliers.
• Liaise with Purchasing and Supplier Quality Engineering to improve the Quality Systems procedures relating to suppliers.
• Identify and capitalise on opportunities for the reduction of cost, yield or quality improvements with existing or new vendors, via process improvement or transfer.
• Assess current internal supplier processes to streamline and optimise.
• Liaise with the Purchasing group to identify new suppliers as needed.
• Liaise with Supplier Quality Engineering and Sustaining Engineering (CAPA) to ensure the effective completion of Supplier Corrective Actions (SCA’s)
• Ensure effective reporting to the Engineering Management team.
• Provide technical support and input when required to the Suppler Audit process.
• Liaise with supplier and regulatory to obtain the supplier related information required for regulatory submissions.

Qualifications

• Ensure the Supplier Engineering team compliant with:
  • Cook’s Code of Conduct.
  • Cook’s Quality System requirements.
  • Company HR policies.

• Liaise with other Cook manufacturing facilities.
• Benchmark systems and processes against best industry practice and modify and develop accordingly to further improve operations efficiencies.
• Responsible for operating general internal quality systems and documentation.

The primary purpose of this position is to lead a team of Engineers focused on the development of processes required to manufacture device designs which are developed by Research & Development in Cook Medical.

Reporting to: Research & Development Manager  

Find out more about Cook Medical here

• Lead a team of Engineers focused on identification, development, and implementation of new processes (within Cook Medical or with third parties) required for the manufacture of device designs which are developed by R&D in Cook Medical.
• Ensure that a risk based approach is applied during the development implementation and validation of all processes both within Cook Medical and with third party suppliers.
• Ensuring that the principle of Design for Manufacture is central to the R&D process and the devices developed within R&D.
• Where appropriate apply Lean Manufacturing principles to the design and implementation of new processes.
• Provide leadership and mentoring to team members to ensure their development and the effective completion of the activities associated with their role.
• Work with the R&D Manager and other Senior Engineers to ensure the appropriate allocation of resources and prioritisation of efforts for the overall R&D group.
• Collaborate with other R&D Teams to ensure the effective completion of all activities associated with an R&D Engineering project / objective.
• Ensure effective reporting to the R&D Manager.
• Work closely to build effective relationships with other functions in particular Operations, Quality and Regulatory teams.
• Supplier selection, process development and validation.
• Support Regulatory Affairs as required with engineering input for process related submissions and renewals prior to and post initial release of devices to market.
• Ensure the effective transfer of products from other Cook entities.
• Provide engineering input and support to those responsible for Supplier instigated changes.
• Liaise with R&D and Process Development teams to ensure the effective transfer of new devices from Development to Sustaining cycles.
• Responsible for process engineering layout plans and implementation in relation to new processes and production lines.
• Provide engineering input and support for the investigation and resolution of Non Conformances associated with devices post release to market.
• Support the post market surveillance of devices in terms of complaint investigation and risk analysis.
• Drive the Cook Medical compliance culture amongst Manufacturing Engineering team members and ensure that compliance requirements are always met.
• Liaise with other Cook manufacturing facilities.
• Support other cross functional groups to achieve company goals.
• Benchmark systems and processes against best industry practice, modify and develop accordingly to further improve operational efficiencies.
• Designee for Manufacturing Engineering Manager/ R&D Manager and Senior Test Engineer.
• Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

• Formal Production/Engineering qualification and relevant experience in the area of NPI and/ or process development
• Strong proven people management skills. Previous experience in a supervisory position desired. The ability to supervise, lead and motivate a group of talented engineering staff.
• Proven project management capability in a project leader role.
• Strong interpersonal skills and the ability to communicate at all levels of the organisation.
• Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.
• Proven problem-solving skills.
• Good computer skills including knowledge of Microsoft® Office.
• Excellent organisational and team building skills.
• High self-motivation.
• Willingness and availability to travel on company business.