SimoTech provides manufacturing automation and IT systems engineering, project management and validation services. We partner with life sciences companies to design, build, operate and optimise critical process automation systems that deliver fast track project delivery, operational efficiency, improve manufacturing agility and achieve regulatory compliance. Why SimoTech What is it like to work at SimoTech? With a strong collaborative teamwork culture based on respect, trust and excellence, we play a critical partnering role to our clients’ life‑changing supply of products to patients. In return, there is excellent salary, benefits, career progression, educational support and much more. SimoTech has an opportunity for an experienced Programme Manager to support delivery of a site‑wide, Digital Transformation strategy. In this role, you will be accountable for leading a cross functional team in conjunction with technical leads to support site transformation projects. Working on site at a large‑scale pharmaceutical facility in Cork, the successful candidate will be responsible for central coordination and oversight of the site development and digitalisation strategic initiative. This will include reporting progress and escalating needs to site leadership teams, resource loading and prioritisation of initiatives and detailed planning and PM oversight of several transformation projects. Key Responsibilities Lead a cross functional team, to develop and deliver an integrated project and programme plan. Build and develop a strong team that encourages open and transparent communication. Collaborate closely with technical leads to ensure objectives are delivered upon and timelines are achieved. Enable effective decision making within the team, particularly under tight deadlines. Communicate effectively with and manage both internal and external stakeholders. Proactively identify and manage issues, developing and executing plans for resolution. Forecast and manage resource requirements in keeping with the integrated plan. Deliver metrics and after‑action reports to relevant governance forums. Identify, recommend and support improvements to business processes and required technical changes. Key Requirements 3rd level Degree or equivalent preferably in a health‑related, scientific or engineering field, or relevant work experience. Minimum of 8 years of experience delivering large scale digital transformation initiatives in large enterprises. Pharmaceutical manufacturing/NPI experience is desirable. Strong knowledge/experience of project management principles for a cross‑functional team, a Project Management certification (e.g. PMP) desirable. Applied knowledge of and experience with Smartsheet is preferable. Excellent attention to details and organisational skills; manage workload, set team priorities and adjust. Ability to work in collaboration multiple functions and combine work streams into an integrated schedule. Demonstrated ability to communicate effectively and influence senior stakeholders and partners across key business areas. Ability to identify bottlenecks and, develop streamlined solutions. High learning agility and flexibility, ability to deal with ambiguity, and uncertainty in a dynamic environment. What SimoTech Can Offer Role provides a high degree of autonomy to allow the successful candidate to reach their full potential. Develop new skills and enhance technical ability by working with innovative technologies in a multi‑disciplined environment. Opportunity to work with large corporate clients on exciting capital projects. #J-18808-Ljbffr
What is it like to work at SimoTech? With a strong collaborative teamwork culture based on respect, trust, and excellence, we play a critical partnering role to our clients’ life‑changing supply of products to patients. In return, there is excellent salary, benefits, career progression, educational support and much more. SimoTech has an opportunity for a Computer Systems Validation Engineer to join our team, supporting our client at a state‑of‑the‑art biotechnology site in Cork. The successful candidate will have 3+ years’ experience in a similar role within the life sciences industry and will support automation projects with a focus on validation activities. This role involves validation support for automation systems and requires strong skills in non‑conformance investigation and technical writing. Key Responsibilities Assist in creating and executing validation strategies for new and existing automation computer‑is‑ded systems. Support the development and execution of CSV strategies for new and existing automated and computer‑is‑ded systems in a GMP environment. Support the implementation and validation of DeltaV DCS and associated automation systems used in life‑sciences manufacturing. Prepare and review validation documentation, including URS, FRS, Validation Plans, IQ, OQ, PQ, traceability matrices, and Validation Summary Reports. Perform risk‑based validation activities in line with GAMP 5 principles and regulatory expectations. Execute validation testing, identify and manage deviations, and support investigations and corrective actions. Support change control activities and assess validation impact for system changes. Provide validation support during internal and external audits and inspections. Ensure compliance with 21 CFR Part 11, EU Annex 11, and site quality procedures. Work collaboratively with Quality Assurance, Automation, Engineering, and IT to maintain validation compliance and continuously improve CSV processes. Qualifications & Experience Bachelor’s Degree in Engineering, Information Systems, Computer Science or Life Sciences. Minimum of 3 years’ experience as a CSV Engineer, supporting DeltaV automation in a pharmaceutical environment. Familiarity with 21 CFR Part 11, EU Annex 11, GAMP 5 and data integrity guidelines. Working knowledge of risk management practices and tools such as FMEA. Strong written and verbal communication skills with the ability to work in a cross‑functional team. Strong attention to detail, organisational and problem‑solving skills. What SimoTech Can Offer Role provides a high degree of autonomy to allow the successful candidate to reach their full potential. Develop new skills and enhance technical ability by working with innovative technologies in a multi‑disciplinary environment. Opportunity to work with large corporate clients. #J-18808-Ljbffr
Whatis it like to work at SimoTech? With a strong collaborative teamworkculture based on respect, trust, and excellence, we play a criticalpartnering role to our clients’ life-changing supply of products topatients. In return, there is excellent salary, benefits, careerprogression, educational support andmuch more. SimoTech has an excitingopportunity for an Audit Trail Validation Engineer to join our team. In thisrole, you will support our client’s Audit Trail team, working across a range ofIT applications within their state‑of‑the‑art laboratory facility in Cork. Thisposition offers a hybrid working model. The successful candidate will contributeto the validation of complex audit trail configurations, ensuring systems meetstringent ALCOA+ and regulatory expectations. Become part of a team committedto excellence in CSV delivery across a cutting ‑ edgelab environment. Key Responsibilities Reviewaudit trails across all laboratory IT systems, assessing user activity, systemchanges, and compliance with data integrity requirements. Loginto each laboratory application to evaluate audit trail entries, determine thenature and impact of recorded changes, and elevate issues where required. Maintainand execute a quarterly audit trail review schedule, ensuring all instrumentsand lab systems are assessed in line with internal procedures and regulatoryexpectations. Support laboratory informatics systems, system administration activities, and the upkeep of validated system configurations. Review vendor release notes and engage with system vendors to understand upcoming upgrades or new features, assessing their impact on validation status and data integrity; prepare summary assessment reports. Support validation activities, including drafting and executing validation protocols, managing change controls, and maintaining IT/CSV documentation in compliance with 21 CFR Part 11, EU GMP Annex 11, and data integrity guidelines. Collaboratewith internal and external partners to ensure laboratory IT systems remaincompliant, secure, and aligned with site procedures and quality standards. Follow all relevant EHS procedures and contribute to incident investigations when required. Activelyparticipate in team meetings, sharing insights from audit trail reviews and contributing to continuous improvement initiatives. Requirements Qualifications & Experience Bachelor’s degree inEngineering, Computer Science, Automation, or a related technical discipline. Basic understanding ofvalidation activities and familiarity with laboratory IT applications. Ability to follow establishedprocedures when implementing changes to IT applications in a GMP or regulatedenvironment. General awareness ofpharmaceutical regulatory requirements, including data integrity principles andgood documentation practices. Proficiency with MS Office,with the capability to follow software setup or configuration instructions. Strong attention to detail andgood analytical/problem‑solving skills. Effective communication andteamwork skills, with the willingness to collaborate across IT, QA, andlaboratory teams. Role is also open to recent graduates who have a strong interest in validation and have completed an internship in this area. What SimoTech Can Offer Role provides ahigh degree of autonomy to allow the successfulcandidate to reach their fullpotential. Develop newskills and enhance technical ability by working withinnovative technologies in a multi- disciplinedenvironment. Opportunity towork with large corporate clients #J-18808-Ljbffr
SimoTech has a great opportunity for an experienced Application Support Engineer to join our team. Supporting our client a leading organisation within the life sciences industry, the successful candidate will play a critical role in maintaining day‑to‑day operational performance across several enterprise applications within a highly regulated environment. This opportunity offers scope to influence system improvements, strengthen operational processes, and contribute to the long‑term efficiency and reliability of digital applications while collaborating with cross‑functional teams. The ideal candidate will bring expertise in technical/application/infrastructure support within a regulated environment, strong communication skills, and excellent stakeholder engagement abilities. Key Responsibilities Develop in-depth knowledge of IT functionality of relevant applications to aid in go-live, upgrade and maintenance activities Provide oversight and ownership for site validation activities associated with digital applications, in accordance with site and corporate procedures and GMP guidelines. Develop a network both on and offsite to help ensure that the site has access to appropriate support teams. Understand the local use cases for globally supplied solutions and ensure that the implementation meets site business needs. Work closely with other site resources to ensure that solutions compliment others already live or planned so avoid duplication of effort. Lead project teams in new and upgrading of technology platforms. Work with the Digital Plant Consultants to help the site strategize on its future technology roadmap. Take part in compliance forums and ensure that all applications under their remit remains in a validated state. Responsible for coordinating periodic tasks associated with live applications. Developing project proposals, schedules and resource needs. Participate in and support audit activities. Ensure that IT site inventory remains accurate. Represent the site and share knowledge at corporate forums. Resolve system problems using data analysis and problem solving skills. Participate, contribute and report at team meetings. Promoting use of system functionality to improve work processes. Interacting with external parties (e.g., vendors, consortiums). Provide troubleshooting/helpto others in the IT department when necessary. Develop and maintain system SOPs. Requirements 5+ years’ experience delivering and supporting IT systems /platforms. Demonstrated learning agility both technically as well as business processes and applications. Demonstrated initiative to build relationships, learn new business processes and identify opportunities. Strong analytical and problem‑solving skills. Strong interpersonal and communication skills. Active listening and leadership skills. Knowledge of IT infrastructure platforms and ISA S95 architecture. Broad knowledge of GMP systems, and knowledge of Industry 4.0 and IoT technology is desirable. Familiar with Agile methodologies. What SimoTech Can Offer Role provides a high degree of autonomy to allow the successful candidate to reach their full potential. Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment. Opportunity to work with large corporate clients on exciting capital projects. #J-18808-Ljbffr
A leading Pharma company in Cork is seeking a Lead DeltaV Automation Engineer to provide technical leadership for DeltaV control systems. The role involves integrating with Syncade MES, guiding a small team, and ensuring compliance with regulatory standards. Ideal candidates have over 8 years of experience with Emerson DeltaV systems and proven skills in troubleshooting and system design. The position offers significant autonomy and development opportunities in a collaborative environment. #J-18808-Ljbffr
Industry Pharma/Biotech/Clinical Research City Cork Country Ireland Job Description Why SimoTech Whatis it like to work at SimoTech? With a strong collaborative teamworkculture based on respect, trust , andexcellence, we play a critical partnering role to our clients’life-changing supply of products t opatients. In return, there is an excellent salary, benefits, careerprogression, educational support andmuch more. SimoTechrequire a Lead DeltaV Automation Engineer for a Pharmaceutical site based inCork. This role will provide technical leadership and oversight for a DeltaVDistributed Control system involving Syncade Manufacturing Execution Systems(MES) helping architectural planning to ensure best practices are adhered to. Thisis a fantastic opportunity for a Lead Engineer to have real impact on the design,implementation and rollout of DCS and MES technologies into an existingmanufacturing site. Theideal candidate will have a minimum of 5 years’ experience in thePharmaceutical/Life sciences industry, deep expertise with Emerson DeltaV,strong understanding of MES interfaces and the ability to guide a smallengineering team. Key Responsibilities Serve as theprimary technical lead for all DeltaV-related aspects of the project. Develop andown the system architecture for DeltaV–MES integration. Provideoversight and guidance to a small team of DeltaV and automation engineers. Lead technical design reviews,system walkthroughs, and troubleshooting sessions. Coordinateclosely with Syncade MES teams for interface design and implementation. Ensure allconfiguration and documentation adheres to GAMP5, 21 CFR Part 11, and sitevalidation standards. LeadCustomer Walkthroughs, commissioning, and qualification activities. Review andapprove DeltaV configuration, modules, phases, and batch recipes. Allocatetasks, mentor junior engineers, and monitor progress against plan. Work withcross-functional teams including Operations, QA, MES. Communicatetechnical status, risks, and mitigations to project leadership. Define dataexchange models between DeltaV and MES, including ISA‑95 alignment. Overseedevelopment and testing of DeltaV Batch interfaces. Produce andreview design documentation: Functional Specifications (FS) Configuration Specifications (CS) Data Mapping Documents Ensuresystem is compliant with regulatory, cybersecurity, and corporate standards. Requirements Key Requirements Bachelor’sdegree in Engineering, Automation, Computer Science, or related field. 8+ years ofexperience with Emerson DeltaV systems (configuration, graphics, batch, I/O,networking). Provenexpertise integrating DCS with MES or Level 3 systems. Experiencewith Syncade. Strongknowledge of ISA‑88/ISA‑95 standards. Experiencein GxP / regulated manufacturing environments (pharma/biotech preferred). Proficiencyin troubleshooting, system design, validation, and documentation practices. Ability to interact andcommunicate with other engineering and business disciplines Comfortableleading a small team with a hands‑on leadership style. What SimoTech Can Offer Roleprovides a high degree of autonomy to allow the successfulcandidate to reach their full potential. Developnew skills and enhance technical ability by working withinnovative technologies in a multi-disciplined environment. Opportunityto work with large corporate clients. #J-18808-Ljbffr
A leading biotechnology firm in County Cork is seeking a Computer Systems Validation Engineer. This role requires at least 3 years of experience in CSV, particularly with DeltaV automation in a pharmaceutical environment. Responsibilities include creating validation strategies, preparing documentation, and ensuring compliance with regulatory standards. The position offers opportunities for professional growth and autonomy while working alongside corporate clients and innovative technologies. #J-18808-Ljbffr
A leading pharmaceutical company in Cork is seeking an experienced Programme Manager to oversee a Digital Transformation strategy. The successful candidate will lead a crossfunctional team to coordinate and manage several transformation projects, ensuring effective communication with stakeholders. Candidates should have at least 8 years of experience in digital transformation initiatives and a 3rd level degree in a relevant field. The role offers autonomy and the chance to work with innovative technologies in collaboration with large corporate clients. #J-18808-Ljbffr
What is it like to work at SimoTech? With astrong collaborative teamwork culture based on respect, trust, and excellence,we play a critical partnering role to our clients’ life‑changing supply ofproducts to patients. In return, there is excellent salary, benefits, careerprogression, educational support and much more. SimoTech has an opportunity for an experienced Programme Manager to support delivery of a site‑wide, Digital Transformation strategy. In this role, you will be accountable for leading a cross‑functional team in conjunction with technical leads to support site transformation projects. Working on site at a large‑scale pharmaceuticalfacility in Cork, the successful candidate will be responsible for central coordination and oversight of the site development and digitalisation strategic initiative. This will include reporting progress and escalating needs to site leadership teams, resource loading and prioritisation of initiatives and detailed planning and PM oversight of several transformation projects. Key Responsibilities Lead a crossfunctional team to develop and deliver an integrated project and programme plan. Build and develop a strong team that encourages open and transparent communication. Collaborate closely with technical leads to ensure objectives are delivered upon and timelines are achieved. Enable effective decision making within the team, particularly under tight deadlines. Communicate effectively with and manage both internal and external stakeholders. Proactively identify and manage issues, developing and executing plans for resolution. Forecast and manage resource requirements in keeping with the integrated plan. Deliver metrics and after‑action reports to relevant governance forums. Identify, recommend and support improvements to business processes and required technical changes. Requirements Key Requirements 3 rd level Degree or equivalent preferably in a health‑related, scientific or engineering field, or relevant work experience. Minimum of 8 years of experience delivering large scale digital transformation initiatives in large enterprises. Pharmaceutical manufacturing/NPI experience is desirable. Strong knowledge/experience of project management principles for a cross‑functional team, a Project Management certification (e.g. PMP) desirable. Applied knowledge of and experience with Smartsheet is preferable. Excellent attention to details and organisational skills; manage workload, set team priorities and adjust. Ability to work in collaboration multiple functions and combine work streams into an integrated schedule. Demonstrated ability to communicate effectively and influence senior stakeholders and partners across key business areas. Ability to identify bottlenecks and develop streamlined solutions. High learning agility and flexibility, ability to deal with ambiguity, and uncertainty in a dynamic environment. What SimoTech Can Offer Role provides a high degree of autonomy to allow the successful candidate to reach their full potential. Develop new skills and enhance technical ability by working with innovative technologies in a multi‑disciplined environment. Opportunity to work with large corporate clients on exciting capital projects. #J-18808-Ljbffr
A leading technology firm in Cork is looking for an experienced Application Support Engineer. The role involves maintaining operational performance of enterprise applications in a regulated environment. Candidates should have over 5 years of experience in IT systems support, strong problem-solving skills, and be familiar with GMP systems. The position offers autonomy, skill development, and the chance to work with large corporate clients on exciting projects. #J-18808-Ljbffr
