Reportingto applicable Manager / Team Leader of the area
SupportingManufacturing areas and all support departments
Key Internal Contacts : Manufacturing, QA, QC, Validation, Regulatory, EHS, Program Management andFinance
Key External Contacts : Equipment vendors, component suppliers, other Genzyme sites, Developmentpharmaceutics groups and benchmarking organisations
Provide leadership andsupport to operations teams to ensure appropriate standards are met
Development andimplementation of improvement initiatives in all manufacturing and developmentoperations
Complaints,LCRs, Deviations, CAPAs support ensuring effective RCA Smart CAPA’s and on timeclosure
Attainmentof SMART goals.
Reductionin process cycle-times.
Ensurecompliance to cGMP at all times
Liaise with externaland internal customers, suppliers and agencies to define and improvemanufacturing and development operations
Optimisation ofmanufacturing and development operations
Identification &implementation of opportunities for improvements
Assist in theimplementation of capital projects
Act as process leadfor inspection development
Lead technical problemresolution & RCA for all manufacturing operations, in conjunction withcross functional teams.
Implementation andmonitoring of performance metrics
Lead cycle timereduction initiatives in conjunction with manufacturing teams
Implementation of bestpractice
Process development programme design / plant trials, execution andimplementation
Constantly seeking to challenge operationalstandards and driving continuous improvement.
Ability to multi task and prioritizeworkload.
Maintain required quality documents in acurrent compliant state.
Subject Matter Expertfor and team resource for new productintroductions / enhancement developmentprojects
Resource for Clinicalsupply provision projects
Aseptic manufacture ororal dose manufacture context
Subject Matter Expertfor product quality attributes and process critical parameters
Design and executionof experimental programmes
Operation of processlaboratories
Scale-up andtechnology transfer project role
Liaison for Clinical supply provision projects
Liaison for Newformulation and product enhancement programmes
Technicalrepresentative for assessment and development of process change control andregulatory submission proposals
Technical support andtrouble-shooting in support of manufacturing activities
Process / productdeviation investigation and resolution
Training delivery oftechnical training programmes
Junior & SeniorTrade’s Certificate or an equivalent third level qualification
At least 5 years’Experience working as a Maintenance Technician in a Multi-skilled Teamenvironment
2 years’ experienceworking as a Maintenance Technician in a pharmaceutical-manufacturingenvironment
Technicalknowledge(theory and practice) ofaseptic manufacturing including lyophilisation considered an advantage
Design of Experimentand associated statistical techniques
Pharmaceutical productdevelopment project life-cycle
Strong report-writingand verbal communication skills
Laboratory and pilotplant skills
Innovation andcreativity skills
Project management skills
StructuredProblem-solving skills Statistical, 6 PIAT
Engineering & Maintenance