Process Engineer

Prochem Engineering; Waterford; On-site; EUR 60,000 - 80,000; Full time

Job summary

Prochem Engineering in Waterford invites applications for a Process Engineer to support a pharmaceutical client. You will lead improvements across manufacturing and development operations, define and implement optimization initiatives, and coordinate capital projects while ensuring cGMP compliance.

Key duties include leading RCA, process development programmes, and collaboration with cross-functional teams to drive efficiency and quality in aseptic or oral dose contexts.

Qualifications

• Degree in chemical, industrial or equivalent engineering.
• Experience with aseptic manufacturing is advantageous.
• Strong knowledge of Design of Experiments and statistics.
• Proven ability to perform RCA and solve problems.

Responsibilities

• Lead and support operations to ensure cGMP standards.
• Identify and implement opportunities for manufacturing improvements.
• Assist in capital project implementations.
• Act as process lead for inspection development.
• Lead technical problem resolution and RCA with cross-functional teams.
• Implement and monitor performance metrics.
• Drive cycle time reduction with manufacturing teams.
• Design and execute experimental programmes and plant trials.
• Maintain compliant quality documents.
• Support new product introductions and enhancements.
• Liaise for Clinical supply and transfer projects.
• Scale-up and technology transfer involvement.
• Ensure ongoing cGMP compliance.

Skills

Process Eng

Aseptic Manufacturing

Design of Experiments

Statistical Methods

Root Cause Analysis

Documentation

Project Leadership

cGMP

Scale-Up

Tech Transfer

Education

Chemical/Industrial Engineering Degree

Advanced Pharmaceutics/Pharmacy (advantage)

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 CAPAs 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
• Strong report-writing and verbal communication skills
• Laboratory and pilot plant skills
• Innovation and creativity skills
• Structured Problem-solving skills - Statistical