Process Engineer UTC
Sanofi
Waterford, County Waterford, Ireland
19d ago

Reportingposition

Reportingto applicable Manager / Team Leader of the area

Workingrelationship

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

Purposeof Role

Provide leadership andsupport to operations teams to ensure appropriate standards are met

Development andimplementation of improvement initiatives in all manufacturing and developmentoperations

ComplianceRelated Tasks

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

JobRequirements

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

Technical reportwriting

Training delivery oftechnical training programmes

Qualifications

Junior & SeniorTrade’s Certificate or an equivalent third level qualification

Experience

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

Skills& Knowledge

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

Research skills

Innovation andcreativity skills

Project management skills

StructuredProblem-solving skills Statistical, 6 PIAT

Engineering & Maintenance

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