Process Engineer

Prochem Engineering; Munster; On-site; EUR 65,000 - 85,000; Full time

Job summary

Prochem Engineering in Waterford, Ireland, is seeking a Process Engineer for a pharmaceutical client. You will lead improvements across manufacturing and development operations, drive CAPA, RCAs and continuous improvement initiatives, and ensure cGMP compliance.

Strong collaboration with cross-functional teams and external partners is essential. The role requires a degree in Chemical/Industrial Engineering, hands-on experience in aseptic or oral dose manufacturing, and proven ability to manage

Qualifications

• Degree in Chemical/Industrial or equivalent engineering discipline.
• Advanced degree in Pharmaceutics, Pharmacy or related science is a plus.
• Knowledge of aseptic manufacturing including lyophilisation is advantageous.
• Design of Experiments and statistical methods.
• Pharmaceutical product development life-cycle.
• Strong report writing and verbal communication skills.
• Laboratory and pilot plant skills.
• Project management skills.
• Structured problem solving – statistical.

Responsibilities

• 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 with cross-functional teams.
• Implementation and monitoring of performance metrics.
• Lead cycle time reduction initiatives with manufacturing teams.
• Ensure compliance to cGMP at all times.
• Liaison for Clinical supply provision projects.
• Liaison for new formulation and product enhancement programmes.

Skills

Aseptic manufacturing

cGMP compliance

DoE (Design of Experiments)

Scale-up / tech transfer

Process development

Statistical methods

Project management

Documentation control

Troubleshooting

Quality systems

Education

Degree in Chemical/Industrial Engineering

Advanced degree in Pharmaceutics/Related science

Job description

Process Engineer required for a pharmaceutical client in Waterford Job

Overview

Provide leadership and support to operations teams to ensure appropriate standards are met. The chosen candidate will be responsible for the development and implementation of improvement initiatives in all manufacturing and development operation.

Job Requirement

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 multitask 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
• 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

Qualifications and Skills

• Degree in Chemical, Industrial or equivalent Engineering discipline
• Advanced degree in Pharmaceutics, Pharmacy or related science discipline considered an advantage
• 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