Manufacturing Process Specialist

Job title:

Manufacturing Process Specialist

Company:

Johnson & Johnson

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.comJob Function: Supply Chain ManufacturingJob Sub Function: Manufacturing Process ImprovementJob Category: ProfessionalAll Job Posting Locations: Ringaskiddy, Cork, IrelandJob Description:About Innovative MedicineOur expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.Learn more at https://www.jnj.com/innovative-medicineWe are searching for the best talent for the Manufacturing Process Specialist role to be in Cork, Ireland.Purpose:The manufacturing process specialist will be responsible for representing operations on capital project teams and supporting first line troubleshooting of the day-to-day activities within operations.You will be responsible for:Representing Operations on cross functional project implementation teams.Monitoring and troubleshooting of the manufacturing process and equipment issues and process optimizationMonitoring and reporting of process performance using statistical process controlTroubleshooting of DCS (e.g Delta V) and PLC control systemsInvestigating and resolving issues raised within the Manufacturing DepartmentParticipateing in/ Leading Cross Functional teams when required.Supporting of Commissioning and Qualification activitiesPreparation and updating of Batch Records, Procedures and Work InstructionsProviding process and equipment related training as required within the Manufacturing DepartmentCompletion of assigned tasks to support manufacture of quality biomedicines in accordance with cGMP and EHS requirements.General Scope of Responsibilities:Lead by example and strive to perform to high standards at all times.Responsible and accountable for assuring the safe accomplishment of job activities, following good environmental practices and procedures. Commit to and demonstrate safe behavior in every activity.Carry out routine and non-routine tasks delegated by the Operations Manager according to appropriate procedures, values, and standards.Carry out all activities in compliance with corporate and cGMP/EHS regulatory requirements.Compliance with Manufacturing and general site procedures at all times.Completion of all documentation in compliance with site procedures and GDP.Execution of activities as necessary to meet operational and business needs.Lead, support and participate in commissioning and qualification activities both current and future projects (and annual re-qualification activities). Also support to validation activities.Prioritize and schedule activities to support business needs and to meet requirements of Master Production Schedule.Lead and Support investigation and resolution of problems on plant.Participate in and lead Cross-Functional teams as necessary.Generate and assist with generation, review, and revision of Manufacturing documentation as necessary.Ensure that personal training requirements are completed in compliance with site procedures. Training and support for new recruits to the Manufacturing groupSupport ongoing studies by Validation, OTS and other support functions.Leadership Responsibilities / Individual ContributionBe familiar with daily activities in manufacturing.Facilitate an environment of continuous improvement and open communication.Lead investigations in work area as necessary.Collaboration and teamwork.Initiative and motivation.Share ideas and suggestions for improvement and encourage others to do the same.Interface with all site departments, Operations and Maintenance.Contact with Engineering, Quality, Logistics, OTS, Validation and Training departments. Contact with other Janssen Biologics sites.Be conscious of internal customers to Manufacturing department and be cognoscente of their requirements.Qualifications / Requirements:Minimum bachelor’s degree in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering.Manufacturing experience within a GMP regulated environment.Experience of the cell culture or purification processesProject / New equipment installation experienceProcess engineering experienceDesirable:Commissioning and qualification experienceExperience of Microsoft Word, Excel and Outlook.Experience of DCS (e.g. Delta V), SCADA and PLC systemsExperience of SAP, LIM’s and/or other business systems.6-Sigma/Kepner-Tregoe or similar problem solving/decision making methodology training.Ability to operate as part of a team with attention to detail.Significant Environmental, Health and Safety ConsiderationsAll employees are required to comply with the requirements of the company’s Environmental, Health & Safety Policy, Safety Statement, associated EHS Procedures, local legislation and duties outlined in the site EHS Manual.In line with the Safety Health & Welfare at Work Act (2005), all employees are required to:Take reasonable care to protect his or her own and the safety of their colleagues who may be affected by their actions.Comply with EHS rules and procedures at all times.Understand the potential EHS impact of their activities.Attend and participate in EHS training as required.Use PPE and safety equipment as required.Report all incidents, accidents, and near miss events.#LI-OnsiteJoin us in shaping the future together—apply now and take the next step in your career with us! #RPOAMS

Expected salary

Location

Ireland

Job date

Thu, 24 Apr 2025 04:52:16 GMT

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