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Process engineer

Sligo
HERO Recruitment
Process engineer
Posted: 11 December
Offer description

Process EngineerDepartment: Technical OperationsReports to: NPI Technical ManagerDuration:12-month contractLocation:Sligo - 100% onsiteTeam:Tech Ops (approx. 10 people) Split intoProcess (equipment)andProduct (NPI)teamsPrimary Focus:Support installation of a new fill-finish lineKey Role:Act as SME for new processes. Collaborate with cross-functional teams (Quality, Ops, Sterility, etc.) for operational readinessRequired Skills:Report writing &Protocol developmentDesirable:Six Sigma (not essential)Experience:3 years in Biologics (fill finish or drug substance)API experience may be considered but not preferredTop Skills Needed:DP fill-finish experience for BiologicsExperience with LYO productsExperience with technical transfer projects (gap assessment, cleaning assessment, etc.)Familiarity with single-use system DP processesResponsibilitiesCore ResponsibilitiesConduct gap analyses, facility fit studies, process safety, and risk assessments for NPI.Monitor and analyse process data during manufacturing.Support development of manufacturing processes for new products.Provide operational technical support for resolving process issues.Prepare and update specifications for NPI materials and consumables.Lead or assist in risk assessments (PFMEA, EHS).Develop NPI documentation:Transfer PlansProtocolsProceduresManufacturing Batch RecordsCollaborate with global science and quality teams on future product development.Lead or assist in investigations and change plans (product/process).Support, supervise, and train operations personnel on NPI processes.Ensure adherence to all EHS&E standards, policies, and procedures.RequirementsEssentialThird-level degree in engineering, science, or technical discipline.DesiredMaster's degree in a relevant technical field.3 years' experience in pharmaceutical process engineering, including:Batch processingTechnical transfersScale-upcGMP environmentBiologics industry experience desirableExperience introducing new products to Biologic facilities.Technical / Business KnowledgeMinimum 1 year in a similar role.Minimum 1 year in Pharmaceutical or Biologics industry.Strong technical and operational knowledge of unit operations in a fill-finish facility.Cognitive SkillsStrong problem-solving skills under pressure.Ability to evaluate multiple viable solutions per problem.Innovative thinker; able to propose and implement new solutions.High attention to detail and accuracy.Results-driven; meets targets and metrics.Strong commitment to quality and compliance.High integrity and strong work ethic.Strong verbal and written communication skills.Strong interpersonal skills.Understands and supports Perfect Performance principles.Ability to prioritise own and team workload.Ownership / AccountabilityAligns with AbbVie Vision, Strategic Imperatives, Operational Pillars, and Ways of Work.Works autonomously; strong self-initiative.Supports execution of commercial product campaigns and NPIs.Partners with EHS&E on safety tasks.Demonstrates tenacity for issue closure.Promotes Right First Time culture.Ensures compliance with cGMP, HPRA/FDA regulations, and company policies.Influence / LeadershipSupports and may lead cross-functional teams and cost-improvement projects.Builds strong relationships with MS&T and GPRD.Provides technical leadership to functional areas.Leads sub-projects related to commercial or NPI activities.Influences leaders on system improvement projects.Contributes to site CJRs, goals, and new Tech Ops initiatives.Selects, motivates, and trains staff; supports Talent Management.Decision Making / ImpactProvides functional expertise to daily operations.Seeks Manager input for significant decisions affecting the area.SupervisionReceived: Operates mostly self-managed; reports to NPI Technical Manager.Provided: May supervise ODP, TDP, or interns as needed.EHS ResponsibilitiesComply with EHS policies and procedures.Maintain personal and team safety awareness.Report incidents or near-misses immediately.Promote EHS improvement opportunities.Attend required training and medical surveillance.Wear PPE as required.

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