• Provide technical support during the NPI process in ensuring that from a Healthcare/Medical device perspective that all FDA, QSR, & MDD standards are achieved and maintained in respect to device classifications.
• Fully competent in the application of quality engineering tools and techniques with key emphasis on validation protocols (DQ, IQ, OQ, & PQ), cGMP, PFMEA's & support the generation of DMF's where appropriate.
• Individual with an experienced background in sterilisation, automation, equipment/software validation.
• Individual with an experienced background in manufacturing within controlled environments.
• Individual shall support the external & internally Quality Management System auditing function (auditor trained).
• Individual shall have exposure & involvement in supporting the CAPA system.
• Close liaison and networking with other departments, to provide and drive quality inputs and initiatives into the overall operational activities of the company.
• Support the implementation of Company Policies and GMP.
• Support all company safety and quality programs and initiatives.
• Ensure ongoing compliance with GMP in all practices, recording of events and processes.
• Ensure compliance with all learnings from all GMP training events.
• Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.

• Degree in Engineering / Science (Mechanical / Electronics / Chemistry) discipline.
• 5 years' experience in a Quality Engineering role in a regulated environment.
• Fully competent in Quality Management Standards.
• People Management experience

Skills/Attributes:

• Excellent Leadership skills, ability to motivate team members within the organisation. (Energetic & enthusiastic individual).
• Excellent organisation, communication, computer & presentation skills.
• Excellent initiative, decision making and be able to work in a core team environment.
• Solution driven with emphasis on performance and results.

• Reports to Site Quality Lead
• Plant wide Teams and Managers.
• Customers, Contractors, Vendors and Suppliers.

Summary:
My client is a bio pharmaceutical company who is looking for a Facilities Engineer to join their team in Waterford. The successful candidate will work as part of the Facilities team on capital projects on site.

Responsibilities:

• Assist facilities engineer with capital projects both project management and execution.
• Projects will include the migration of live commercial manufacturing and sampling suites to a QBMS.
• Facility modifications to convert from soft gel manufacturing to accommodate commercial granulation suite.
• Introduction of new facility equipment on site to serve sterile manufacturing facility.
• Annual shutdown including HVAC and clean utility requalification to ISO.

Qualifications & Experience:

• Degree in Engineering.
• 5 years’ experience as a Facilities Engineer in a similar environment.
• Pharmaceutical experience is essential.
• HVAC, QBMS, compressed air and nitrogen plant equipment experience is strongly desired.

Are you a Manufacturing Engineer? Would you like to be part of an ever-growing team that understands the importance of on-time delivery and support to their customers while also providing high quality, reliable, and compliant products?

Job Responsibilities

• Design manufacturing processes, procedures and production layouts.
• Develop SOP’s and guide operations on training.
• Ensure processes and procedures comply with relevant regulations.
• Work with customers internally and externally as well as partners to deliver projects.
• Utilize LEAN, Six Sigma and other best practices tools and principles daily.
• Write and execute process and equipment validation (IQ/OQ/PQ).
• Guide operations regarding design concepts and specification requirements.

Job Requirements

• Level 8 in Mechanical, Biomedical or related Engineering/Science discipline.
• Hands-on experience in Medical Device Assembly.
• 4+ years of experience in a highly regulated environment.
• Proven track record in the execution of protocols and validations.
• Experience in managing validation activities and cost reduction projects.
• Technical knowledge of Automated Systems (Pneumatic, Electro-pneumatic, Robotic)

For a confidential discussion on this or any other current job opportunity please contact Meggan on 021 235 9144 / mtully@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.

Are you a Validation and Quality Engineer? Would you like to be part of an ever-growing team that understands the importance of on-time delivery and support to their customers while also providing high quality, reliable, and compliant products? Then this might be the role for you!!

Job Responsibilities

• Create concise and accurate on-time technical reports.
• Create and evaluate metrics to drive quality improvements.
• Determine root cause of problems using CAPA/8D/A3 Problem Solving.
• Lead and conduct internal audits.
• Lead risk assessments (FMEA)
• Develop validation documentation-plans protocols, procedures.
• Track and resolve deviations.
• Compile relevant documentation from suppliers for inclusion in validation protocols and reports.
• Assist in the development of training material for qualification activities.

Job Role

• Level 8 in the relevant field.
• Experience in validation of manufacturing processes and clean room environment.
• 5+ years’ experience in a Production environment
• 5+ years’ experience in Quality department
• 5 years Customer complaints management experience
• GMP experience
• ISO 9001-13485 CFR 820 knowledge

For a confidential discussion on this or any other current job opportunity please contact Meggan on 021 235 9144 / mtully@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.

The Company

We are a growing Irish Fintech dedicated to building the latest technologies to transform how data is managed, pro-cessed and leveraged by the Funds industry. Fund Recs operates as a remote company and has physical offices in Waterford, Dublin and New York.

Our no-code reconciliation and data transformation software takes on mundane, repetitive jobs and fully automates them, giving customers back valuable time to better serve their clients.

About you

We are looking for Junior Technical Support Engineers to join our Technical Support Engineering Team. 

A Technical Support Engineer will be reporting to and mentored by the Lead Technical Support Engineer and tasked with providing trusted, timely and accurate responses to customers queries and technical issues. 

They will be tasked with troubleshooting issues, identifying root causes, sometimes through liaising with developers and fixing or escalating the issue where appropriate. They will be expected to keep accurate records of discussion or correspondence while tracking issues through to resolution. 

Together with the rest of the Team they will participate in the development of tools, systems, and processes which aim to identify improvement opportunities for both the customers and internal processes by improving product supportability and driving innovation and quality to improve overall operational efficiency.

This is a permanent, full-time position. The entire Fund Recs team is currently working remote and we are committed to being a remote friendly workplace after it is safe to return to the office.

Responsibilities

Key responsibilities will include:

• Work independently and as part of a software development team. Collaborate and work closely within an inclusive agile environment alongside engineers, product managers and other stakeholders
• Keep up-to-date with competitor products, best practice standards, latest industry trends
• Adhere to and promote internal information security policies and procedures
• Keep accurate records of discussion or correspondence while tracking issues through to resolution
• Plan and conduct user research and competitor analysis; interpret data and qualitative feedback
• Live to problem solve; breaking complex concepts into smaller more management components, with the ability to explore multiple solutions and explain trade-offs and decisions along the way

Requirements

Essential:

Have a technical degree in a relevant discipline (IT, Computer Science, Software Engineering etc) or equivalent work experience.

1-2 years of relevant work experience.

Be self-motivated, flexible and a quick learner.

Able to work to a deadline, alone and as part of a team.

Have a strong technical and problem-solving ability.

Strong interpersonal skills and ability to establish strong working relationships with colleagues and clients.

Focus on the customer and solving their problems.

Always be looking for a better way to do things and be willing to question convention.

Essential:

• Strong communication, and organizational skills

Technologies we use Today

We use Groovy/Grails, Java, MySQL, Hibernate, tomcat, jQuery, React. We make extensive use of AWS, including EC2/VPC/ELB/AutoScaling/S3/SQS/RDS/ElasticCache.

Experience using the above is a bonus but not a requirement. We like quick learners and if you can bring in tools we're not already using, all the better.

To Apply

Treating people with respect, and providing equal opportunities for employment, growth and advancement is of the utmost importance to us. We want to attract people who will challenge, question, push boundaries and know well be better for it. If this sounds like you lets chat.

Apply by sending your CV to: jobs@fundrecs.com 

About Fund Recs

Fund Recs (www.fundrecs.com) is a growing Irish Fintech building software to transform how data is managed, processed and leveraged by the Funds industry. Our no-code reconciliation and data transformation software takes on mundane, repetitive jobs, such as processing valuations, and fully automates them, giving customers back valuable time to invest in better serving their clients. Founded in 2013 Fund Recs has offices in New York, Dublin and Waterford, Ireland.

An expanding employer in the South has a vacancy for a Validation Engineer at their GMP facility. As part of a small dedicated team you'll work on a diverse range of products including equipment qualification, thermal mapping and CSV. For the right candidate a strong salary and benefits package is on offer for these roles which is on days.

About the Job:

• Calibration, Installation, Operation & Performance qualification (IOPQ) of Laboratory equipment
• Maintenance of schedules: Calibration, Qualification, Preventative Maintenance & re-qualification of equipment.
• Execution of CSV (GAMP, RA, ERES Assessment) on lab Equipment.
• Hosting & executing Installation, Operation & Performance qualification (IOPQ) of new equipment
• Execution of temperature mapping on CTU (generating protocols, review, approval & execution).
• Maintain the Validation Helpdesk generating reports & metrics and completing own assignments.
• Calibration of equipment
• Checking and signing off external certificates of calibration and generation internal certificates for same.
• Ensure that all documentation is carried out on time, is accurate and legible and conforms to cGMP.
• The execution of Temperature control mapping on CTU’s & ambient areas

About You:

• Primary degree in Life Sciences or Engineering
• At least 2-5 years’ experience in a laboratory or GMP regulated environment is desirable; preferably with Calibration/Validation experience.
• Previous experience in GMP regulated environment.
• Awareness of pharmaceutical processes for equipment calibration and validation.
• Excellent technical writing, communication and organisational skills.
• Quality oriented with the ability to consistently work to industry and client standards.
• Experience with documenting analytical data and writing reports.
• Passionate about quality and customer service.
• Experience in IOPQ & understanding on GAMP for Lab equipment would be desirable

For more on the role call Nigel on 087 3618142 or send your CV for consideration.

The Company

We are a growing Irish Fintech dedicated to building the latest technologies to transform how data is managed, processed and leveraged by the Funds industry. Fund Recs operates as a remote company and has physical offices in Waterford, Dublin and New York.

Our no-code reconciliation and data transformation software takes on mundane, repetitive jobs and fully automates them, giving customers back valuable time to better serve their clients.

About you

We are looking for a seasoned Senior Software Engineer to join our engineering team. 

The ideal candidate must enjoy writing smart algorithms, suggest better architecture and defend their code with test cases. The successful candidate will have plenty of opportunity to contribute ideas and to shape the roadmap of our products.

This is a permanent, full-time position. The entire Fund Recs team is currently working remote and we are committed to being a remote friendly workplace after it is safe to return to the office.

Responsibilities

Key responsibilities will include:

• Take full ownership of implementing features, from development to deployment
• Work independently and as part of a software development team
• Provide mentoring to junior team members on engineering best practices

Requirements

Essential:

• 5+ years of software development experience for enterprise software products
• Experience building secure SaaS products
• Proficiency in Spring Boot or Grails, Java or Groovy, ORM, Git
• Proven ability to follow best coding practices, and apply design patterns where applicable
• Solid understanding of relational databases and working knowledge of NoSQL databases
• Experience implementing high quality code using automation and unit testing frameworks
• Experience with designing and implementing large scale integration solutions
• Experience with REST, including good API design and versioning
• Proven ability to balance multiple priorities
• Experience with Agile development process

Desirable:

• Knowledge of Docker or Kubernetes
• Experience with AWS especially Cloud Formation, S3, SQS, EKS, DynamoDB
• Strong communication, and organizational skills
• BS/MS in Computer Science, Engineering, or related field

To Apply

Treating people with respect, and providing equal opportunities for employment, growth and advancement is of the utmost importance to us. We want to attract people who will challenge, question, push boundaries and know well be better for it. If this sounds like you lets chat.

Apply by sending your CV to: jobs@fundrecs.com 

About Fund Recs

Fund Recs (www.fundrecs.com) is a growing Irish Fintech building software to transform how data is managed, processed and leveraged by the Funds industry. Our no-code reconciliation and data transformation software takes on mundane, repetitive jobs, such as processing valuations, and fully automates them, giving customers back valuable time to invest in better serving their clients. Founded in 2013 Fund Recs has offices in New York, Dublin and Waterford, Ireland.

One of the South East's most attractive employers has a vacancy for an experienced Controls Engineer. Working in a dynamic and expanding site you will execute projects in a fast paced, multi-disciplined, cross-functional team environment. This role offers the opportunity to work on exciting new tech.

About the Job:

• Manage production and the introduction of new technology through team leadership.
• Provide technical and vision core competency support to Global Operations and Engineering on an as-needed basis, including possible off-hours, remote and onsite coverage rotation.
• Provide Technical support and technical reference expertise to manufacturing and outside vendors in developing technical solutions for vision inspection technologies.
• Project Management/ support of capital projects within the plant to drive increased volume and decreased cost across multiple manufacturing processes.
• Provide Technical specification documents to external vendors for the purpose of trending and design/ build of new manufacturing equipment.
• Support product, platform and cost improvement programs by delivering qualified vision systems. Interface with Engineering, SQA, QA and Operations to successfully validate software systems. Author and execute associated validation documents.
• Provide technical and operations training on systems delivered.
• Travel to vendor and other locations for on-site project support (domestic & international
• Vendor management
• Deliver projects on time and within budget

• Electronics/ Electrical Engineering
• Computer/Software development systems
• PLC- Allen Bradley, Siemens
• High Level language Programming e.g. C#, VB.net
• Practical knowledge of machine vision systems including Cognex VPro and InSight desired
• Methodical/Analytical approach to problem solving.
• 3 - 5 years relevant experience
• FDA regulated Medical Device
• Project Management
• PLC Software Development
• Scada Software development
• Manufacturing support
• Development, documentation and approval of technical documentation