The Product Engineering (PE) group is responsible for the provision of technical support to the Production and QC groups, product re-design, process improvement, product integration, new product introduction and product transfer. The Product Engineer will report to the NPI Supervisor and the Business Development Manager.
Roles and Responsibilities:
• Subject Matter Expert (SME) for Lateral Flow product family.
• Provide technical support for the Rapids/Lateral flow manufacturing and QC group.
• Facilitate the resolution of technical issues by leading, designing and executing root cause investigations in a timely manner.
• Be an active learner and self-motivator, and consistently seek to attain a higher level of knowledge and experience in In-vitro Diagnostics.
• Be proactive in problem identification and process improvement by trending of manufacturing data and monitoring ongoing robustness of products.
• Ensure the timely generation and completion of necessary technical reports and justifications, and facilitate the efficient completion and closure of documents including NCMRs, Change Controls, and CAPAs etc.
• Have the ability and commitment to work to deadlines alone and as part of a team.
• Show a full commitment to quality policy and adhere to the quality systems
• Support the introduction and transfer of new products from R&D or third parties to the facility.
• Review, revise, and create documentation as requested.
• Carry out team specific duties within the Product Engineering group.
Skills and Behaviours:
• The successful applicant will have excellent communication skills, (both written and verbal), excellent interpersonal and presentation skills, and be team focused.
• Meticulous report writing and laboratory notebook keeping.
• Ability to lead and provide support and advice on Lateral Flow Products.
• Ability to make decisions based on technical understanding to ensure that products are technically sound and meet quality requirements.
• Actively learn and have a willingness to learn further about Lateral Flow Products.
• Willingness and ability to collaborate with and influence other individuals and groups in a positive, team-based environment.
• Ability to work independently where necessary.
• Professional characteristics will include initiative, ingenuity, creativity, resourcefulness, and perseverance.
• Ability to design, execute, analyze, and interpret experimental work.
• Pay attention to detail and work with a sense of urgency and have the ability to be impartial and objective.
• Be an active learner and developer of self and others with excellent organisational skills.
Education and Experience:
• A minimum degree in biological/biomedical sciences, Microbiology Biotechnology, Biochemistry or Chemistry is essential.
• Post-doctoral experience would be preferred.
• A minimum of 3 years’ experience within the IVD industry, with proven extensive laboratory experience in In Vitro diagnostics is essential.
• Experience in protein conjugation is essential.
• Experience in protein coating on nitrocellulose membrane is essential.
• Experience in handling blood-based samples and infection disease agents.
• Demonstrated experience in problem-solving and creativity in resolving product or process problems for IVD products.
• Demonstrated competence in a wide range of statistical concepts including Design of Experiments.
• Experience in HPRA/WHO and/or FDA Regulatory requirements.
For a full Job Spec and to apply for this role please call Katie on +353 1 895 5770 or e-mail email@example.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671