Instrumentation Engineer

Aphex Group; Carlow; On-site; EUR 60,000 - 90,000; Full time

Job summary

Aphex Group in Ireland seeks a QC Systems & Instrumentation professional to ensure cGMP compliance and drive continuous improvement across laboratory instrumentation. You will oversee external calibration activities, coordinate audits and lead cross-functional projects to enhance lab capability.

The role requires a degree in Chemistry/Science, strong data integrity knowledge, and Lean Six Sigma experience, with proficiency in MS Office and vendor management. On-site in Carlow, Ireland.

Qualifications

• Bachelors degree or higher, ideally in Chemistry/Science or related discipline.
• Experience in a Manufacturing/Laboratory environment, preferably GMP.
• Knowledge of cGMP and GDP preferred.
• Knowledge of data integrity requirements.
• Proficiency in Microsoft Office and related applications.
• Lean Six Sigma methodology experience desired.

Responsibilities

• Drive compliance with cGMP, GDP and global policies in day-to-day activities.
• Provide technical oversight for external vendor calibration PM/OQ activities.
• Lead day-to-day oversight for external vendors and collaboration with suppliers.
• Facilitate communication to ensure testing and validation activities stay on schedule.
• Coordinate audits and inspections, supporting readiness and compliance.
• Review instrumentation lifecycle, commissioning and qualification documents.
• Lead continuous improvement and root cause analysis for equipment issues.
• Represent QC in site projects and cross-department initiatives.
• Manage resources for improvement ideas and merit-based projects.

Skills

Data integrity

cGMP knowledge

GDP knowledge

Microsoft Office

Lean Six Sigma

Education

Bachelor's degree or higher in Chemistry/Science or related

Job description

Responsibilities

• Work as directed by Lab systems & Instrumentation manager according to Company safety policies, cGMP and cGLP. Required to drive compliance with Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
• Technical oversight and review for external vendor calibration PM/OQ activities on Laboratory Instruments.
• Leadership activities including day to day oversight for external vendors.
• Facilitate and drive effective communication to ensure success.
• Attend tier meeting for Lab systems and instrumentation function and other support functions as necessary ensuring that the relevant group representatives attend to confirm all testing and validation activities are on schedule.
• Liaise effectively with instrumentation/ equipment vendors, service suppliers, and outsourced services etc.
• Author or peer review instrumentation lifecycle, commissioning and qualification test documents.
• Participates in any efficiency/ increased Lab capability projects as detailed by Systems / Instrumentation Coach.
• Represent the QC Department on site/inter departmental projects.
• Provide support with audit/inspection requirements to ensure department compliance/readiness.
• Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
• Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why's etc.
• Provide input, review and approval for atypical, observation, and process capability investigations.
• Oversee coordination of resources to implement suggestions/ideas of merit.
• On assignment, and depending on experience, participate in or lead departmental initiatives on improved compliance and quality systemsGMP and cGLP.
• Required to drive compliance with Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions..
• May be required to perform other duties as assigned.

Requirements

• Bachelors Degree or higher preferred; ideally in Chemistry/Science or a closely related discipline
• Considerable experience and critical skills in the area of expertise that add value to the business; ideally in similar role in a Manufacturing/Laboratory environment, preferably in a GMP setting
• Knowledge of cGMP and GDP preferred
• Knowledge of data integrity requirements required.
• Proficiency in Microsoft Office and job related computer applications required
• Lean Six Sigma Methodology experience desired