We believe that through close collaboration with our clients we can enable them to embrace the next wave of manufacturing technology. Central to this is our customer relationship and our dedicated team.
We partner with our clients so that we are an integral part of their team. We strive to go above and beyond expectations to ensure that our clients get projects/processes/installs/systems completed on time.
We invest in our team. Our people are what our reputation is built on. We care about supporting the growth of all our employees and making sure they feel professionally fulfilled. We are extra devoted to developing young talent. No matter what your background we believe if you are motivated and enthusiastic we can make you into a top class engineer.
One of our core values is continuous improvement and learning for all our team. We invest heavily in ensuring our employees are developing their skills and progressing. Working with Réalta Technologies you will have the opportunity to work on projects from small standalone systems to multi million euro projects. We will make sure you get exposure to projects and technologies that you are interested in.
We offer a competitive benefits package that includes:
Be part of a fast growing team
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The successful candidates will join a team focused on supporting manufacturing within the Engineering department. This team ensures all goals and targets of the manufacturing process are achieved through the continuous development of manufacturing processes and the support of day to day operations. This position will provide project experience on continuous improvement, and risk mitigation initiatives and may also include liaison with outside suppliers.
Réalta Technologies are currently working with a major Medical Device client involved in discovering, developing, and delivering innovative Medical Devices. This is a great opportunity to join a Digital team which is driving change and enabling key technology & software capabilities. You will provide support for the computerised systems that are being implemented as part of a major capital projects to ensure compliance with regulatory expectations and CSV, SDLC, Cyber Security and Data Integrity requirement. He/she will actively contribute to the overall validation strategy and liaise with relevant technical and business units to drive consistent and compliant approach across the systems.
· Manage, co-ordinate, develop and execute thequalification and validation deliverables for automation projects.
· Providing input into the validation strategyfor computerised systems, including leveraging approach.
· Develop and/or review SDLC deliverables suchas: Requirement Specification, Requirements
· Traceability Matrix, Functional Specification,Design Specification, Code Review, Test
Specification/Test Script
· Support activities include, but are notlimited to; the preparation of Validation/Qualification
· Plans, Risk Assessments, User RequirementSpecification, Traceability Matrix, Testing (IQ, OQ/PQ), Data Migration, SOPsand Change controls.
· Responsible for ensuring that computerizedsystems are in full compliance with regulatory requirements, company policiesand procedures. This individual will provide compliance leadership, directionand execution in Computer System Validation for new projects and existingassets connected to the automation network.
· Support the resolution of projectdeviations/errors and provide quality guidance on GxP regulatory requirements(including but not limited to 21 CFR Parts 11, 820 and EU GMP Annex 11
· Draft qualification protocols and supportequipment qualification activities.
· Ensure compliance with site procedures, cGMP,recognized quality standards and regulatory expectation.
Principle Accountabilities:
· Process Automation Excellence
· Documentation development and review.
· cGMP
· Strong compliance background
· Experience with ISA S95 and S88 standard
· Experience of Testing GAMP Category 3, 4 &5 systems & knowledge of CFR 21 Part11
o Third Level Qualification in Automation, IT Systems, Electronic/MechatronicEngineering.
o Ability to interpret engineering drawings/specifications.
o Working knowledge of Medical Device Quality Systems (FDA/ISO) within a
regulated environment.
Key competencies required:
· High Attention to Detail
· Pro-active approach to Work
· High Standards
· Flexible
· Excellent Communication Skills
· Analytical Skills
· Team Player
· Highly Computer Literate
· Planner & Organiser
· Active Listener
· Continuous Improvement Focused
· Experience in the biotechnology and/or pharmaceutical industry, (preferably both).
· Demonstrated understanding of continuous quality / process improvement tools (As defined by the local site, e.g. DMIAC, Lean QA, 5S etc).
· Experience with working in a multinational organisation.
The candidate will provide technical support for the Foxboro DCS System at one of our biggest pharma clients' sites. This will involve maintaining system reliability and performance by troubleshooting and diagnosing existing or potential System faults, implementing latest software/security patches and modifying existing control logic and operator displays. International engineers that need relocating are welcome.
We're currently looking to grow one of our Automation teams at a key pharma client's & hiring for DeltaV Engineers with a mix of experiences from Junior to Lead Engineers ready to work in Cork or relocate to Cork. At Réalta, we have an excellent benefit package & well-established career progressions. Please see some brief information on some of your responsibilities.
- Involved in the development & Design Specifications for Process Control Systems within a Pharma/Bio-tech environment.
- Assist in the generation of Requirements Specification Documents
- Development of Graphical User Interfaces
- Integration of new equipment IOs to DeltaV systems with DeltaV blocks- Involvement with OSI PI Content
- Must hold a minimum of a third-level degree Bachelor’s degree in Automation engineering, Computer Science or equivalent
- Capable of working within a project team to achieve results
- Skilled in the use of problem-solving tools/techniques an advantage
- Ability to approach projects with sound analytical, troubleshooting, and problem-solving skills
- Excellent communication and interpersonal skills
- Ability self-motivate and operate independently
- Innovative and quick thinking
- Strong attention to detail
- Excellent organisational and time management skills
Proven hands-on experience on DeltaV implementation
We are currently recruiting a Computer Systems Validation (CSV) Engineer for the implementation of a large-scale automation project in a Pharmaceutical Site. The project is an extension & upgrade of an existing facility. You'll be supporting with introducing a DeltaV system & electronic batch reporting where previously the facility was paper-run. You would also support Introducing lyophilizes & autoclaves & work on a few different packages. Work would also involve supporting the technical engineering team as well as CSV deliverables with design documents (Kneat). RTMs, IOQs - executing in Kneat
· Development of ValidationPlans, Installation Qualifications (IQs), Operational Qualifications (OQs) andSummary Reports.
· Prepare, execute, document andreport validation protocols in line with GMP’s and other regulatoryrequirements and standards.
· Assure that all validationtest procedures are in line with current technology, corporate and governmentalregulations.
· Ensure that the ValidationStrategy meets the quality requirements of its customers and applicableregulations FDA, EU & International Standards
· Review and Approve validationprotocols and assessments from a quality system documentation perspective.
· Liaise with Engineering /Automation and external vendors regarding equipment documentation, HDS, SDS,FDS, User Requirement Specifications (URS’s), and any other associatedvalidation issues.
· Participate and communicate asrequired in project activities.
· Develop procedures to managecomputerised systems where required.
· Develop and present projectplans to project management senior staff.
PRINCIPLEACCOUNTABILITIES:
· Validation Strategy.
· Quality input for new product & processintroduction.
· Documentation development and review.
· cGMP.
· Third Level Qualification in Automation, IT Systems, Electronic/MechatronicEngineering.
· 4 Years’ experiencein CSV role
· Experience in Pharma, Bio-Pharma, Med Devices
· Experience with computer System Validation
· Experience in CSV of automation projects inlife science industry.
· Ability to interpret engineering drawings/specifications.
· Working knowledge of Medical Device QualitySystems (FDA/ISO) within a regulated environment.
· Experience in Kneat, HP ALM, DeltaV, PLC, MES, PI
· Good knowledge of control systems
· Good knowledge of IT manufacturing systems
Réalta Technologies are currently working with a major Medical Device client involved in discovering, developing, and delivering innovative Medical Devices. This is a great opportunity to join a Digital team which is driving change and enabling key technology & software capabilities.
What you will do:
Automation Systems
Collaboration &Teaming
Experience
Essential
Key Competencies Required
This role is to Lead the delivery of an MES project in a pharmaceutical plant in Cork. The candidate will be required to work closely with the Automation IT project team responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.
This role is to Lead the delivery of a Data Historian project in a pharmaceutical plant in Munster/Leinster. The candidate will be required to work closely with the Automation IT project team responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.
The successful candidates will join a team focused on supporting manufacturing within the Engineering department. This team ensures all goals and targets of the manufacturing process are achieved through the continuous development of manufacturing processes and the support of day to day operations. This position will provide project experience on continuous improvement, and risk mitigation initiatives and may also include liaison with outside suppliers.
This role is for a Computer System Validation (CSV) Engineer based at a Biotech facility in Limerick. This person is responsible for authoring GxP computer validation and CFR 21 Part 11 related documentation such as assessments, plans, URS, FRS and summary reports.
We are currently recruiting for a number of Automation Engineers on behalf of our Client. Experience ranging from 2 years and up to more senior 5+ years experience.
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