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Process Engineer UTC

Sanofi Group
Waterford
32 days ago: Sanofi Group

Job Description

Description

 

Reporting position

Reporting to applicable Manager/Team Leader of the area

Working relationship

Supporting Manufacturing areas and all support departments

Key Internal Contacts: Manufacturing, QA, QC, Validation, Regulatory, EHS, Program Management and Finance

Key External Contacts: Equipment vendors, component suppliers, other Genzyme sites, Development pharmaceutics groups and benchmarking organisations

Purpose of Role

Provide leadership and support to operations teams to ensure appropriate standards are met

Development and implementation of improvement initiatives in all manufacturing and development operations

Compliance Related Tasks

Complaints, LCRs, Deviations, CAPAs support ensuring effective RCA Smart CAPA’s and on time closure

Attainment of SMART goals.

Reduction in process cycle-times.

Ensure compliance to cGMP at all times

Job Requirements

Liaise with external and internal customers, suppliers and agencies to define and improve manufacturing and development operations

Optimisation of manufacturing and development operations

Identification & implementation of opportunities for improvements

Assist in the implementation of capital projects

Act as process lead for inspection development

Lead technical problem resolution & RCA for all manufacturing operations, in conjunction with cross functional teams.

Implementation and monitoring of performance metrics

Lead cycle time reduction initiatives in conjunction with manufacturing teams

Implementation of best practice

Process development programme design / plant trials, execution and implementation

Constantly seeking to challenge operational standards and driving continuous improvement.

Ability to multi task and prioritize workload.

Maintain required quality documents in a current compliant state.

Subject Matter Expert for and team resource for  new product introductions /  enhancement development projects

Resource for Clinical supply provision projects

Aseptic manufacture or oral dose manufacture context

Subject Matter Expert for product quality attributes and process critical parameters

Design and execution of experimental programmes

Operation of process laboratories

Scale-up and technology transfer project role

Liaison for Clinical supply provision projects

Liaison for New formulation and product enhancement programmes 

Technical representative for assessment and development of process change control and regulatory submission proposals

Technical support and trouble-shooting in support of manufacturing activities

Process/product deviation investigation and resolution

Technical report writing

Training delivery of technical training programmes 

Qualifications

 

Junior & Senior Trade’s Certificate or an equivalent third level qualification

Experience

At least 5 years’ Experience working as a Maintenance Technician in a Multi-skilled Team environment

2 years’ experience working as a Maintenance Technician in a pharmaceutical-manufacturing environment

Skills & Knowledge

Technical knowledge(theory and practice)  of aseptic manufacturing including lyophilisation considered an advantage

Design of Experiment and associated statistical techniques

Pharmaceutical product development project life-cycle

Strong report-writing and verbal communication skills

Laboratory and pilot plant skills

Research skills

Innovation and creativity skills

Project management skills

Structured Problem-solving skills – Statistical, 6PIAT

Job

:   Engineering & Maintenance

Description   Reporting position Reporting to applicable Manager/Team Leader of the area Working relationship Supporting Manufacturing areas and all support departments Key Internal Contacts: Manufacturing, QA, QC, Validation, Regulatory, EHS, Program Management and Finance Key External Contacts: Equipment vendors, component suppliers, other Genzyme sites, Development pharmaceutics groups and benchmarking organisations   Purpose of Role Provide leadership and support to operations teams to ensure appropriate standards are met Development and implementation of improvement initiatives in all manufacturing and development operations   Compliance Related Tasks Complaints, LCRs, Deviations, CAPAs support ensuring effective RCA Smart CAPA’s and on time closure Attainment of SMART goals....