Serialisation & Automation Support Engineer (GMP)

Ethypharm; Morebath; On-site; GBP 40,000 - 55,000; Full time

Benefits offered by this job

Competitive salary

Holiday 25–30 days + bank holidays

Holiday Buy/Sell up to 5 days

3% Bonus discretionary

Bravo Benefits Platform

Salary Sacrifice for Electric vehicles

Private Healthcare

Pension Scheme

Job summary

Ethypharm is seeking a Technical Support Engineer to provide specialist technical support for serialisation, automation and associated packaging line systems in a GMP-regulated pharmaceutical environment. You will troubleshoot, configure, validate and ensure data integrity to support compliant production.

You will act as the technical lead on serialisation, develop recipes, assist with batch start-up and investigate deviations while collaborating with maintenance and QA teams to sustain optimum

Qualifications

• HNC/HND or equivalent qualification in Engineering, Automation, Electrical/Electronic Engineering or a related technical discipline.
• Strong working knowledge gained through equivalent practical experience may be considered.
• Experience supporting serialisation, automation or packaging line systems in a manufacturing environment.
• Experience troubleshooting equipment, system faults and data/communication issues.
• Experience working in a GMP, regulated or highly controlled operational environment.
• Understanding of packaging machinery, automation principles, GMP, GxP and ALCOA+ data integrity expectations.
• Working knowledge of PLC/HMI systems, servo drives, VFDs, sensors, scanners, printers and vision systems.
• Awareness of controlled documentation, SOPs, change control and validation lifecycle requirements.

Responsibilities

• Act as the technical point of contact for serialisation and associated automation systems on packaging lines, providing timely fault diagnosis, root cause analysis and resolution.
• Develop, configure, maintain and verify serialisation recipes, line formats, product master data and system parameters in line with approved procedures and change controls.
• Support production batch start-up, line clearance, batch execution and post-batch review activities where serialisation or automation systems are involved.
• Investigate serialisation deviations, system alarms, reject trends, communication failures and equipment faults, supporting effective CAPA and prevention of recurrence.
• Support installation, commissioning, qualification and validation activities, including IQ/OQ/PQ, periodic reviews and computerised system lifecycle documentation.
• Ensure serialisation and automation systems are operated and maintained in compliance with GMP, GxP, ALCOA+ data integrity principles and applicable serialisation regulatory requirements.
• Retrieve, analyse and trend data from serialisation, vision inspection, automation and OEE systems to identify issues, improve line performance and support operational decision-making. Support PLC/HMI systems, servo drives, VFDs, sensors, scanners, printers and vision systems, escalating complex issues appropriately.

Skills

Serialisation systems

Automation systems

Data integrity

GMP compliance

PLC/HMI knowledge

Diagnostics & troubleshooting

Validation basics

Education

HNC/HND in Engineering

Tools

PLC/HMI

Vision systems

Job description

Ethypharm is seeking a Technical Support Engineer to provide specialist technical support for serialisation, automation and associated packaging line systems in a GMP-regulated pharmaceutical environment. You will troubleshoot, configure, validate and ensure data integrity to support compliant production.

You will act as the technical lead on serialisation, develop recipes, assist with batch start-up and investigate deviations while collaborating with maintenance and QA teams to sustain optimum