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 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

• 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.

• 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.

Summary:
Our client is a global biopharma company based in Carlow and is looking for a Process Engineer who will provide technical support for commercial manufacturing and new product introduction. The right candidate will perform product risk management and quality risk management and will Design/ Author/ Review/ Approve/ Execute process development studies in support of new product introduction and ongoing manufacturing support and qualification/validation documentation and studies in line with the standard approval process.

Responsibilities:

• Serve as technical support for commercial manufacturing and new product introduction.
• Product risk management and quality risk management.
• Management of change.
• Design/ Author/ Review/ Approve/ Execute process development studies in support of new product introduction and ongoing manufacturing support.
• Provide technical input into quality notification by authoring/reviewing/approving investigations.
• Execution of equipment/qualification validation programs; including re-qualification and re-validation.
• Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process.
• Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
• Statistical data analysis to support development and commercialisation batches.
• Support continuous improvement through Lean Six Sigma methodologies.
• Leading and active participation in projects, system failure investigations and investigation reports.
• Execution/development of change controls.
• Contribution to Kaizen events as appropriate.
• Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.
• Implement subsequent corrective action through the change management system.
• Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
• Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
• Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
• Key process engineer in the commercial products engineering team to address and lead any management of changes, risks, impact assessments etc. associated with the commercial products.
• Role will report to Technical Engineering commercial support coach.

Qualifications & Experience:

• Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
• 3-5 years’ Engineering/Technical experience; ideally in manufacturing, preferably GMP Setting.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Report, standards, policy writing skills required.
• Equipment and process validation.
• Sterile filling processes and equipment.
• Proficiency in Microsoft Office and job related computer applications required.
• Data analysis experience required.
• Lean Six Sigma Methodology experience desired.

SensL is the leading provider of low light sensors based on its solid-state single photon avalanche diode (SPAD) and silicon photomultiplier (SiPM) technology. SPAD and SiPM sensors are a disruptive and enabling technology that replaces the aging vacuum tube based photomultiplier, avalanche photodiode and PIN photodiode. The main markets for our products are in Medical Imaging, Radiation Detection and Automotive LiDAR for ADAS and Autonomous Vehicles. SensL has pioneered the production of its sensor technology in high volume, industry standard, CMOS fabrication facilities delivering unprecedented performance, uniformity, quality, reliability and low cost. SensL enables OEM customers to develop new classes of products based on our low light sensors performance, size, robustness and low power operation. SensL provides the ideal candidate with a unique opportunity to work with a profitable, growing, high tech company involved in the latest technology trends such as self-driving vehicles, cancer detection and cloud based radiation monitoring.

The Process Engineer will be a member of the engineering team, working directly with SensLs foundry partners on process and test development and assist in process improvement of existing production processes.

Experience and Skills Desired

• Experience with process development and CMOS process module integration.
• Experience with statistical data analysis techniques and excellent analytical and problem-solving skills.
• Experience in failure analysis and debug of semiconductor processes.
• Experience working with production test and volume data analysis.
• Ability to work closely with others in a cross-functional team environment.

Qualifications

• M.Sc. in Electrical Engineering, Microelectronics, Optoelectronics or Physics
• 2+ years of working experience in a wafer fabrication facility
• Excellent verbal and written communications skills
• Strong interpersonal skills and an ability to work well in a team.

Benefits

This position carries an attractive salary, stock options, health coverage and employer pension contribution. This position is full time and based at SensLs corporate headquarters in Cork, Ireland.

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.

• Strong knowledge of finished product packaging operations and track record leading in a high volume regulated environment.
  • Understanding of pharmaceutical industry regulatory requirements as they apply to packaging.
  • Strong leader of operations personnel with direct supervision experience.
  • Strong communication and interpersonal skills. Highly motivated with ability to work effectively with multidisciplinary teams.
  • Strong team player with proactive approach & manner.

• Bachelor’s Degree in Science/Manufacturing/Engineering or equivalent.

• 5+ years relevant experience in a pharmaceutical manufacturing or similar environment with at least 3+ in a supervision/leadership capacity.
• Demonstrated experience in managing the day-to-day activities of a packaging/manufacturing team.
• Skilled at motivating a multifunctional team to achieve organizational goals.
• Comfortable developing and implementing a timeline to achieve targets.
• Demonstrated experience in managing performance, delegating tasks and coaching and training team members to maximize their potential.

• Lead and be the subject matter expert in the assigned process engineering group.
• Provide daily guidance and communication to Engineering Technicians through daily PVD, email and follow up meetings as appropriate.
• Provide support to operations to optimize existing processes and to ensure that production goals are met.
• Monitoring equipment performance to lead/support improvement activity to reduce downtime events and yield losses.
• Drive process improvements through identification of problem areas/opportunities and collaboration with internal groups and external vendors using Lean/Six Sigma and project management techniques.
• Lead the complete validation of new and existing equipment including acceptance trials, debugging, process development, and final validation.
• Development and coordination of related documentation, including standard operating procedures, set-up guides, validation documentation.
• Engage with vendors on the development, design, and evaluation of equipment and/or processes requiring novel and innovative approaches in technology.
• Liaise with corporate R&D in the development of new projects and ensure that project timelines are met.
• Participate in the continuous improvement programs.
• Coordinate planned maintenance activities and process parameter records.
• Support the requirements of ISO13485 and quality system procedures including promoting and complying with cGMP.
• Assist with QNs, customer complaints and CAPA investigations.

This job is an opportunity for an experienced planning engineer / scheduler with strong MS Project planning skills and exposure to industrial projects.

The job is based in the Kildare area on a permanent basis and carries the opportunity to work on large scale installation projects with international clients.

About the Job:
- Responsible for all planning works associated with the procurement, installation and commissioning of industrial equipment
- Maintenance of installation schedule
- Track planned versus actual progress and produce reports on same
- Attending site meetings (internal and client based)
- Liaising with site installation and commissioning teams for regular updates
- Monitoring original costs for scope growth/changes
- Producing accurate reports regarding any project delays and causes of same (eg site readiness)

About You:
• You will have a relevant third level qualification (ideally degree or similar qualificaton in electronics, electrical or mechanical engineering)
• You will have a minimum of 5 years post qualification experience in a similar role
• You will be highly competent in the use of MS Project
• Good understanding of the wider project controls functions
• Ability to chair and run Interactive Planning and coordination meetings

If this sounds like something you might be interested in, please send your CV to rwalsh@sigmar.ie or call Richard at 01 4744688 for more information.

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.