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.

• Designing and implementing new features to agreed timelines, both on your own and as a member of a feature-driven team
• Provide leadership and mentoring to other team members
• Comfortable representing team and presenting to management
• Proactively improve processes to help deliver a better product
• Maintaining and support of new and existing features by liaising with the Development, QA and Support Teams to diagnose and resolve issues
• Design and write quality, scalable and robust code with security and performance in mind
• Contribute in all phases of the software development lifecycle (SDLC)
• Develop technical documentation for internal use
• Communicate effectively in a fast-paced environment where priorities may change depending on workload
• Constantly improve skills and knowledge through self-learning and share with the team to help achieve overall goals
• Translate business requirements to technical concepts

• Bachelor’s Degree or College Diploma in a computer science-related course
• Extensive experience developing enterprise level applications preferably using Node.js frameworks such as Express or Hapi
• Experience with Amazon Web Services (AWS) or Digital Ocean
• Extensive experience developing RESTful APIs. Must have a good working knowledge of Postman
• Designing and implementing relational databases such as PostgreSQL
• Experience with cloud native deployments using Docker and Kubernetes
• Experience of working within an Agile environment using Scrum
• Knowledge of MVC and other software design patterns, including SOLID principles
• Excellent teamwork ethic with the ability to work collaboratively with others (technical and non-technical)
• Flexible and adaptable, with the ability to align to changing priorities
• Excellent verbal and written communication skills in English

• Experience with Domain-Driven Design (DDD)
• Project experience with Microservices
• Experience with Vue.js, Angular or React
• Experience with Swagger
• Experience using CI/CD (for example Jenkins or Travis)
• Experience with; Redis, GraphQL, NoSQL, TypeScript/ ECMAScript, System Administration
• Experience with Test-Driven Design (TDD)
• Working knowledge of OAuth and/or SSO (Single Sign-On)
• Familiarity with UNIX/ Linux and Shell scripting
• Good understanding of visual and UX design principles

• Microsoft Windows Server (2012 / 2016 / 2019) and LAN troubleshooting.
• Resolve technical escalations covering a wide variety of technical issues.
• Troubleshooting experience relating to Microsoft Server OS, Microsoft Office 365, Microsoft Azure, Group Policy and DNS, Active Directory management, print management.
• Diagnose and resolve network-related technical problems, IP subnet and routing, firewall configurations, managed switches, wireless network configurations etc – Hardware and Software -related.
• Assisting with Hyper- V, server migration projects and client cloud migration projects
• Designing and implementing DR solutions.
• Troubleshooting Backup Solutions – experience particularly with Ashay, Veeam, Unitrends.
• Experience setting up and configuring Microsoft Azure Cloud and Intune
• Experience with FortiGate, Draytek, SonicWALL firewalls, Ubiquity devices an advantage

• Ideally you will have a Third level technical degree or master’s qualification in a technical discipline.
• Ideally you will have a MCSE, Microsoft O365 Administrator, CCNA, Networking qualification.
• Ideally you will have a Min of 10 years IT support Networking and troubleshooting experience in a similar role.
• Excellent technical aptitude and troubleshooting skills.
• Ability to handle multiple tasks concurrently and provide final level call escalation.
• A strong customer-focused communicator with excellent interpersonal skills.
• Candidates must also be proactive, self-motivated and capable of working without close supervision.
• Full clean driving license is essential.

• A competitive package, including fully expensed Company Vehicle, on-call allowance, home office allowance, educational and training allowance, and the opportunity to become a senior part of the growing technical team.
• Prior experience essential, applicants must be business level English speaking, be fully eligible to work in Ireland long term and have very strong customer service skills. All technical positions undergo a pre-screening technical interview.

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.

Are you a Manufacturing Engineer with strong problem solving & validation skills? This could be the perfect role for you!

This company is a leader in medical devices spaces based in county Waterford!

Job responsibilities:

• Designing manufacturing processes, procedures, and production layouts. 
• Developing manufacturing processes and measurement systems.
• Developing relevant work instructions and SOP’s and provides guidance to operations on training.
• Providing guidance to operations regarding design concepts and specification requirements.
• Ensuring processes and procedures are in compliance with regulations.
• Delivering and managing projects within an agreed schedule.
• Working with internal and external customers and partners to deliver on projects.
• Utilizing LEAN, Six Sigma, and other best practice tools and principles for day-to-day problem solving and continuous improvement.
• Writing and executing process and equipment validations (IQ/OQ/PQ).

Job Skills & Experience:

• 3rd Level Engineering Degree with a good hands-on working knowledge of medical device assembly.
• 4+ years of relevant experience in a highly regulated environment, 
• Proven track record in the execution of protocols and validations to regulatory requirements.
• Successful track record of project managing validation activities and cost reduction projects.
• Technical knowledge of Automated Systems (Pneumatic, Electro-pneumatic, Robotic)
• LEAN, Six Sigma experience
• Monitoring of materials, equipment and process flows during validation and ramp-up related activities to ensure high levels of performance and OEE.
• Process background (development, capability, optimization, validation) within a regulated industry.

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

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.

• 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.

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 an experienced JavaScript developer who is proficient with React.js. 

The primary focus of the selected candidate would be on developing user interface components implementing and executing them following well-known React.js workflows (such as Flux or Redux). 

A commitment to collaborative problem solving, sophisticated design, and quality products are important.

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:

Developing the latest user-facing features using React.js

Designing a modern highly responsive web-based user interface

Building reusable components and front-end libraries for future use

Translating designs and wireframes into high-quality code

Learn and understand user interactions.

Optimizing components for maximum performance across a vast array of web-capable devices and browsers

Coordinating with various teams working on distinct layers

As a React.js Developer, you will be involved from conception to completion with projects that are technologically sound and aesthetically impressive.

Take ownership of tasks, implementing features, from development to deployment.

Work independently on mini UI projects, and as part of a software development team.

Requirements

Essential:

2+ years of software development experience for enterprise software products

Strong proficiency in JavaScript, including DOM manipulation and the JavaScript object model.

Thorough understanding of React.js and its core principles

Familiarity with RESTful APIs

Experience with common front-end development tools such as Babel, Webpack, NPM, etc.

Ability to understand business requirements and translate them into technical requirements.

Familiarity with code versioning tools such as Git.

Proven ability to follow best coding practices where applicable.

Desirable:

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.