Operations Lead – Biotech Plant

Job title:

Operations Lead – Biotech Plant

Company:

JobContax

Job description

Operations Lead – Biotech Plant – Dun Laoghaire, DublinOffice/Project Location: Dun Laoghaire, DublinEmployment Type: ContractWork Location: Site basedPay: €35 – €42 per hourExperience: 3+ yearsVisa: EU passport or Stamp 4 visa requiredOur client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoghaire, South Dublin.The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.This is an excellent opportunity to get experience into Ireland’s leading aseptic manufacturing plant.Operations Lead will serve as primary production process owner responsible for New Product Introduction, Life Cycle Management Projects and/or CAPEX projects and established process improvements projects.This role requires in-depth technical and operational knowledge of aseptic Drug Product manufacturing processes; Parts/Components Preparation, Formulation, Syringe Filling, Vial Filling, Lyophilisation and Capping.You will be the operations point of contact for coordination of the manufacturing effort and will be responsible for driving process efficiencies as part of the project for operations.You will apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to ensure streamlined manufacturing operations are enabled in both vial and syringe facilities.Function as the site interface between the Product Delivery Teams (PDT’s), and Manufacturing operations.Engaging with staff members within the Manufacturing department to ensure understanding of the processes and working collaboratively cross functionally with Facilities & Engineering, Quality, PD and Supply Chain.Develop, review, and approve Generic Master Batch Records and Parameter Value Lists across Formulation, Filling and InspectionDevelop, review and update Production, Engineering, Operating Procedures & training materialsAssist in providing training on scientific or technical aspects of the current process/project(s) to Direct ManufacturingEvaluate, plan, and implement solutions for process improvement opportunities both current and project related.Support scheduling and execution of Characterisation, Engineering and PPQ runs, ensuring all necessary pre-requisites are included on the schedule and assess process performance by observation of floor operations and review of performance dataProvide troubleshooting support throughout the project and on the floor during execution of activitiesHold people to account for delivery and behaviors within the Manufacturing Support team and associated with the project(s)Perform Job Hazard Assessments and Change Control Assessments to determine impact to ManufacturingPartner with Learning & Performance to define training strategies for current processes, NPIs and complex projectsConsult with Quality Assurance to ensure that GMP standards are maintained in line with current SOP’s, batch documentation and licencesDevelop, review and update Protocols for manufacturing activitiesDocumentation and approval of protocol deviations for manufacturing activitiesConsult with Process Development, Direct manufacturing, Equipment, and System Owners regarding process changes in an effective and timely mannerOwn and lead change controls as required by the Manufacturing support teamReview and approve Bills of MaterialsDevelop, review and update Product Quality Risk AssessmentsRequirementsBachelor’s degree in a science discipline.3+ years of biopharmaceutical manufacturing experience in Fill Finish or related manufacturing or GMP experience in the pharmaceutical or medical device industry.Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.Strong Project Management and organizational skills, including ability to follow assignments through to completionCritical thinking skills: Gathers data from key stakeholders, analyses and interprets information to develop solutions to technical problems of moderate complexityNegotiation and Influencing skillsTake initiative to identify and drive improvementsExcellent verbal and written communication skills: Strong Technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good Presentation skillsEscalate issues professionally and in a timely mannerDecision Making skills and confidence to challenge others on decisions that impact the manufacturing areaTeamwork and Coaching othersEnsures compliance within regulatory environmentDemonstrated ability to work independently and deliver right first-time results under minimal directionPackageContract role – Hourly rate €35 – €42 per hourMinimum 12 month contract with the possibility of an extension.Operations Lead (4-day on-site requirement)Shift Patterns8 hour days operating over a 5 day week (Monday – Friday).2 week rota.Week 1 Morning Shift: 07:00 – 15:00 (Mon – Thurs) 07:00 – 14:00 (Fri).Week 2 Evening Shift: 14:30 – 22:30 (Mon – Thurs) 13:30 – 20:30 (Fri).Alternating pattern, so if on morning shift week 1 then on evening shift week 2 and so on.20% shift premium applied.On-CallOn-call cover for weekends from 07:00 Saturday – 19:00 Sunday (excluding nights).Rostered on-call.Must be able to attend site if required over both days.Now they have a lot of PPQ activities coming up due to the new vile line we’ll be asking for volunteers for a 3-to-4-week period for the PPQ’s.There will be volunteers to go on the two-cycle shift pattern & then the other ask is, if you’re not going on the shift pattern can you do on-call for the weekends.ContactKaren McHugh is the consultant managing this position.If you are an Operations Leadinterested in roles based in Dublin , you can contact Karen by e-mail at karen@jobcontax.com Karen or phone 353 1 7979720 for a confidential chat.JobContax do not send CVs to clients without candidate permission.With over 50 years of technical recruitment experience, JobContax is the leading recruiter of Operations Leads in Dublin and Ireland.Due to the large volume of applications, JobContax may not be able to respond to every individual.taglife

Expected salary

€35 – 42 per hour

Location

Dublin

Job date

Thu, 27 Mar 2025 23:13:42 GMT

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