Manufacturing Engineer
- Recruiter
- Confidential
- Location
- Ballina
- Salary
- Competitive
- Posted
- 25 Jun 2022
- Closes
- 15 Jul 2022
- Sectors
- Engineering
- Contract Type
- Permanent
- Hours
- Full Time
Manufacturing Engineer
LGC's Clinical Diagnostics Business Unit develops and manufactures a comprehensive portfolio of catalogue and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, and pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline - from concept and early-stage research, through expedited product development and onwards into routine clinical use. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics, and clinical genomics rely on LGC's products to support accurate and reliable diagnostic results.
Our operating entities include Technopath Clinical Diagnostics, which is highly regarded as a leader in the IVD industry, having developed a first-of-its-kind range of consolidated immunochemistry quality control products.
The Native Antigen Company, which is a manufacturer and supplier of antigens and antibodies, these are key components in vaccine research, and for the accurate diagnosis of a wide range of infectious diseases. SeraCare Life Sciences and Maine Standards are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials).
Our 450+ employees operate an ISO 9001-accredited facility in Tipperary (Ireland), Oxford (UK), and FDA-registered and ISO 13485-accredited facilities in Maine, Massachusetts and Maryland, USA.
Each day, our world-class staff, scientific expertise, operational efficiency, and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics.
Manufacturing Engineer Job Duties and Responsibilities:
*
Ensure that the manufacturing process operates effectively and efficiently
*
Responsible for planning, execution and documentation of Installation, Operation and Performance Qualification (IQ, OQ, PQ) activities for new manufacturing processes and equipment as per quality system requirements
*
Complete validation assessments on Product/Process and Facility, Utility and Equipment change controls as required by other areas
*
Facilitate CFT meetings and risk assessments (e.g. FMEA) in order to develop validation strategies and as required
*
Manage validation records in keeping with internal documentation practices and capable of producing validation records during audits
*
Be the Process owner for the Manufacturing processes and ensure that these processes are optimised
*
Drive best practice in areas such as 5 pillars, lean principles into the team
*
Implement cost reduction initiatives in the production processes via a culture of continuous improvement
*
Execute protocols for new manufacturing processes and equipment (including acceptance tests etc)
*
Work closely with other departments within Operations to maintain and enhance equipment performance, (filling equipment, process equipment) to ensure production, quality and safety targets are met
*
Updating of process and equipment operating/maintenance procedures in line with GDP
*
Publish KPIs to your direct manager and provide updates on a regular basis on projects and the overall manufacturing process feeding into existing tier SQIDP reporting structure
*
Perform other related tasks as assigned by manager
Manufacturing Engineer Skills and Qualifications:
* Degree in Engineering/Chemical/Sciences or equivalent experience
* A minimum of 3-5 years' experience in an engineering role in a Biotechnology/Pharmaceutical/Medical Device environment
* Proficient in technical writing including but not limited to validation protocols and associated test plans for change controls
* Strong project management skills
* Ability to take ownership and deliver results within agreed timelines and budget
* Excellent written and oral communication skills
* Excellent analytical ability
* PC literate with good working knowledge of Microsoft Excel, PowerPoint, Word & MS Project, Minitab
The successful candidate will be able to demonstrate the following behaviours in line with LGC's Core Values:
*
Passion: Pride in our achievements engenders passion for our work and it translates into our ambition to make the world a safer place
*
Curiosity: We constantly look forward to what's next: our curiosity for today's discoveries makes tomorrow's innovations possible
*
Integrity: A commitment to high ethical standards has been at the heart of LGC since we started testing the integrity of products in 1842
*
Brilliance: We strive to be the very best in everything we say and do. We exceed customers' expectations through innovation and pioneering science
*
Respect: We respect gender, age, nationality, religion and individuality - our diversity is our strength
LGC's Clinical Diagnostics Business Unit develops and manufactures a comprehensive portfolio of catalogue and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, and pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline - from concept and early-stage research, through expedited product development and onwards into routine clinical use. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics, and clinical genomics rely on LGC's products to support accurate and reliable diagnostic results.
Our operating entities include Technopath Clinical Diagnostics, which is highly regarded as a leader in the IVD industry, having developed a first-of-its-kind range of consolidated immunochemistry quality control products.
The Native Antigen Company, which is a manufacturer and supplier of antigens and antibodies, these are key components in vaccine research, and for the accurate diagnosis of a wide range of infectious diseases. SeraCare Life Sciences and Maine Standards are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials).
Our 450+ employees operate an ISO 9001-accredited facility in Tipperary (Ireland), Oxford (UK), and FDA-registered and ISO 13485-accredited facilities in Maine, Massachusetts and Maryland, USA.
Each day, our world-class staff, scientific expertise, operational efficiency, and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics.
Manufacturing Engineer Job Duties and Responsibilities:
*
Ensure that the manufacturing process operates effectively and efficiently
*
Responsible for planning, execution and documentation of Installation, Operation and Performance Qualification (IQ, OQ, PQ) activities for new manufacturing processes and equipment as per quality system requirements
*
Complete validation assessments on Product/Process and Facility, Utility and Equipment change controls as required by other areas
*
Facilitate CFT meetings and risk assessments (e.g. FMEA) in order to develop validation strategies and as required
*
Manage validation records in keeping with internal documentation practices and capable of producing validation records during audits
*
Be the Process owner for the Manufacturing processes and ensure that these processes are optimised
*
Drive best practice in areas such as 5 pillars, lean principles into the team
*
Implement cost reduction initiatives in the production processes via a culture of continuous improvement
*
Execute protocols for new manufacturing processes and equipment (including acceptance tests etc)
*
Work closely with other departments within Operations to maintain and enhance equipment performance, (filling equipment, process equipment) to ensure production, quality and safety targets are met
*
Updating of process and equipment operating/maintenance procedures in line with GDP
*
Publish KPIs to your direct manager and provide updates on a regular basis on projects and the overall manufacturing process feeding into existing tier SQIDP reporting structure
*
Perform other related tasks as assigned by manager
Manufacturing Engineer Skills and Qualifications:
* Degree in Engineering/Chemical/Sciences or equivalent experience
* A minimum of 3-5 years' experience in an engineering role in a Biotechnology/Pharmaceutical/Medical Device environment
* Proficient in technical writing including but not limited to validation protocols and associated test plans for change controls
* Strong project management skills
* Ability to take ownership and deliver results within agreed timelines and budget
* Excellent written and oral communication skills
* Excellent analytical ability
* PC literate with good working knowledge of Microsoft Excel, PowerPoint, Word & MS Project, Minitab
The successful candidate will be able to demonstrate the following behaviours in line with LGC's Core Values:
*
Passion: Pride in our achievements engenders passion for our work and it translates into our ambition to make the world a safer place
*
Curiosity: We constantly look forward to what's next: our curiosity for today's discoveries makes tomorrow's innovations possible
*
Integrity: A commitment to high ethical standards has been at the heart of LGC since we started testing the integrity of products in 1842
*
Brilliance: We strive to be the very best in everything we say and do. We exceed customers' expectations through innovation and pioneering science
*
Respect: We respect gender, age, nationality, religion and individuality - our diversity is our strength