GMP Compliance Engineer - Sterile Ops & Documentation

Prochem Engineering; Leinster; Sur place; EUR 55 000 - 80 000; Plein temps

Résumé du poste

Prochem Engineering in Ireland's Carlow site is seeking an Engineering Compliance Specialist to ensure GMP and sterile environment compliance, safety, and reliable product supply. You will drive deviations, CAPAs, engineering change controls, and document control to maintain regulatory readiness.

Collaborating with IPT, Quality, EHS and technical engineering, you will review and author controlled documents, perform root cause analyses, and ensure timely completion of tasks in accordance with

Qualifications

• Diploma or higher preferred in a related discipline
• Prior experience in a manufacturing GMP setting is desirable
• Excellent communication and interpersonal skills to interface with all levels
• Knowledge of Irish, European and international regulatory requirements
• Sterile filling processes and equipment experience preferred
• Proficiency with Microsoft Office and related computer applications

Responsabilités

• Direct and lead deviations and out-of-tolerance investigations with root cause analysis and CAPA implementation
• Support engineering documentation review (electronic logs)
• Support audit readiness activities
• Support internal audit programs
• Collaborate with Engineering, IPT, Quality, EHS and other departments to maintain compliance
• Comply with cGMP and contribute to a safe, compliant site culture

Connaissances

Effective communication

Interpersonal skills

Microsoft Office proficiency

Team collaboration

GMP knowledge

Formation

Diploma or higher in related discipline

Outils

Microsoft Office

Description du poste

• We are seeking an Engineering Compliance Specialist to join the Engineering Department at our client’s Carlow site, supporting operations in a GMP and Sterile Environment.
• This role is essential for ensuring compliance, safety, and reliable product supply.
• Key responsibilities include generating and expediting the review of Manufacturing GMP documentation such as deviation reports (QNs) and corrective and preventative actions (CAPAs), leading Engineering change controls and supporting permanent inspection readiness.
• The Compliance Specialist will also author, edit, and review controlled documents, collaborate within cross-functional teams to solve problems using Root Cause Analysis (RCA) methodologies, and ensure timely completion of documentation to maintain compliance with regulatory requirements.

Core Duties and Responsibilities:

• Direct and/lead deviations, out of tolerance conditions and unexpected results, conducting failure analysis, root cause determination and implementing corrective and preventative actions.
• Supporting Engineering documentation review - e.g. electronic logs
• Supporting Audit Readiness activities.
• Supporting Internal Audit programs
• Collaborate with Engineering colleagues and other departments particularly IPT, Quality, EHS, Technical Engineering in completion of tasks and maintaining compliance posture.
• Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions. Work collaboratively to drive a safe and compliant culture on site. May be required to perform other duties as assigned.

Minimum Qualifications and Experience:

• Diploma or higher preferred, ideally in a related discipline.
• Would typically have prior-related work experience; ideally in a manufacturing GMP setting.
• Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
• Sterile filling processes and equipment experience preferred.
• Proficiency in Microsoft Office and job-related computer applications
• Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers
• Understand the specific responsibilities of all departments on site as they relate to one’s own department, understanding the business processes one’s department supports
• Effective time management and multi-tasking skills