Orion Group Life Sciences are currently recruiting a Process Engineer on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11-Month contract with potential to extend.Hybrid role after training.Our new team member will serve as technical support for new product introduction (NPI) and commercial manufacturing and will participate and/or lead cross functional or single function teams including liaising with vendors or above site groups. You will typically have prior related work experience; ideally in manufacturing, preferably GMP Setting but we will consider applicants from other working environments as long as they have technology transfer experience Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable but not a necessity for this role Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. What you will do: Bring energy, knowledge, innovation, and leadership to carry out the following: Design/Author/Review/Approve/Execute qualification/validation documentation and process development studies in line with the standard approval processDesign/Author/Review/Approve/Execute Execution/development of change controlsContribution to Kaizen events as appropriateTechnical input into quality notification by authoring/reviewing/approving investigationsExecution of equipment/qualification validation programs; including re-qualification and re-validationSupport continuous improvement through Lean Six Sigma methodologiesPerform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issuesServe as technical engineering representative for internal technical group discussions and represent technical Operations Carlow at global technical forumsDrive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around complianceWork collaboratively to drive a safe and compliant culture in CarlowMay be required to perform other duties as assignedWhat skills you will need: In order to excel in this role, you will more than likely have: Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical disciplineMin 3 years' experience ideally in manufacturing, preferably GMP SettingDemonstratable experience of leading technical related projectsEvidence of continuous professional development is desirableKnowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable but not a necessityKnowledge of regulatory/code requirements to Irish, European and International Codes, Standards and PracticesReport, standards, policy writing skills requiredEquipment and process validationSterile filling processes and equipmentProficiency in Microsoft Office and job-related computer applications requiredExcellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated mannerHybrid role once successful completion of training, occasional shift support as required based on program needsOur role in supporting diversity and inclusionAs an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.