Process Technician Serialisation

About PCI Pharma Services

PCI Pharma Services is a global leader committed to delivering life-changing therapies by partnering with thousands of biopharma companies and their patients. Our people drive innovation, progress, and build a better future by shaping the pharmaceutical industry's next wave of development.

Role Overview

The Process Technician Serialisation serves as a critical member within the Engineering team at PCI's Ireland sites, acting as the Subject Matter Expert (SME) for serialisation processes. This role focuses on enhancing production efficiency through accurate data management, troubleshooting hardware and software issues related to serialisation, and ensuring compliance with serialisation regulations. The role includes training colleagues, supporting continuous improvement initiatives, and leading system validation and risk management activities.

Key Responsibilities

• Own assigned serialisation process(es), becoming the site SME by educating and training others while working with vendors to understand and optimize technology capabilities.
• Lead or assist with Continuous Improvement projects, including Overall Equipment Effectiveness (OEE) initiatives to increase operational efficiency and reduce waste and costs.
• Maintain and update the Technical Drawing and serialisation equipment specification database, managing documentation including creation, filing, and archiving of superseded materials.
• Manage serialization data, including master data attributes and resolving data transfer issues.
• Support the development and optimization of internal serialisation workflows prioritizing waste reduction and efficiency enhancements.
• Develop Engineering team’s knowledge and competence in evolving serialisation technologies to meet business goals.
• Ensure all serialisation activities are compliant with regulatory requirements and maintain related documentation.
• Participate in system validation and risk assessment for new or modified equipment and processes.
• Collaborate with Operations to review and resolve technical, product, and process issues as needed.
• Support implementation of new serialisation systems and upgrades to existing setups.
• Adhere to all statutory, regulatory, health and safety, cGMP, and company technical standards and procedures.
• Create and promote a work environment aligned with PCI Pharma Services’ core values and behaviors.
• Manage or participate in ad hoc projects and tasks relevant to department and business needs within the scope of expertise.

Scope and Authority

• Responsible for compliance with company SOPs, health and safety standards, cGMP, and regulatory guidelines for self and team members.
• May manage and maintain budgets for capital projects as appropriate.

Equal Employment Opportunity

PCI Pharma Services is dedicated to fostering an inclusive and diverse workplace, offering equal employment opportunities without discrimination on any protected grounds including race, gender identity, disability, veteran status, and more. We are committed to upholding values of fairness, respect, and equal opportunity across all organizational levels.