Process Technician Serialisation

PCI Pharma Services; Leinster; On-site; EUR 45,000 - 65,000; Full time

Job summary

PCI Pharma Services is seeking a Process Technician Serialisation to join our Stamullen site in County Meath. You will act as the SME for serialisation processes within Engineering, troubleshooting hardware and software issues and driving improvements.

The role requires strong technical skills, teamwork and the ability to lead CI projects, ensuring compliance with regulatory requirements and maintaining critical documentation across systems.

Qualifications

• Experience troubleshooting serialisation hardware and software.
• Strong technical ability with good interpersonal and communication skills.
• Ability to lead continuous improvement actions and optimise processes.

Responsibilities

• Take responsibility for an assigned serialisation process and act as site SME.
• Support and lead CI projects to improve OEE, reduce waste and costs.
• Maintain and update the technical drawing and serialisation equipment data base.
• Manage serialization data including master data attributes and data transfer issues.
• Support development of internal serialisation processes/workflows to reduce wastage.
• Build and sustain knowledge within the Engineering team for evolving serialization technologies.
• Ensure compliance with serialisation regulatory requirements and manage data to maintain compliance.
• Support system validation activities and maintain related documentation.
• Assist risk assessment for new or modified equipment and processes.
• Collaborate with Operations to resolve operational issues and review performance.

Job description

Stamullen, Co. Meath, IRL

Drogheda, Co. Loeth, IRL

IRL_Dundalk

Full time

JR

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

We are now looking for a Process Technician Serialisation (Permanent role) to join our team in Stamullen, County Meath.

Justification

The Process Serialisation Technician will have important roles on supporting production for improving operational efficiency through accurate data management, troubleshooting serialisation hardware and software issues, anticipating serialisation issues in NPI implementations and ensuring PCI Serialisation process is in accordance with actual regulatory compliance. He will also support developing other stake holders in serialisation process and will lead implementation of continuous improvement actions to optimize the serialization process, reducing downtime and costs associated rework.

Main purpose of job:

Working within the Engineering function for PCI Pharma Services (Ireland Sites) the Process Technician Serialisation will act as the Subject Matter Expert (SME) for assigned serialisation processes within the technical function of Engineering. The Process Technician Serialisation will display strong technical ability and have interpersonal and communication skills that build the strongest of relationships at department and site level.

The Process Technician Serialisation will have a proven track record in troubleshooting serialisation equipment issues (Hardware and Software) and be capable of understanding and optimising system performance, be strong in a team environment and possess excellent coordination skills.

Main responsibilities:

• Take responsibility for an assigned serialisation process(es) and become the site SME educating and training others. Work with vendors to better understand the technology and seek to maintain and optimise it's capability to benefit site and customer projects.
• Assist and or lead Continuous Improvement (CI) Projects and operational issues as required, including all OEE (Overall Equipment Effectiveness) projects to ensure improved efficiencies, reduced waste and cost.
• Population and maintenance of the Technical Drawing & serialisation equipment specification data base, this is to include the generation, recording, filing and archiving of withdrawn / superseded Technical Drawings and associated documentation.
• Manage serialization data, including master data attributes, and address data transfer issues.
• Support the development of PCI internal serialisation processes/workflows with an aim to reduce wastage and improve efficiencies across various workstreams and initiatives.
• Build, develop and sustain the knowledge, capability and competency within the Engineering team to support ongoing and changing serialisation technologies employed to meet the business objectives.
• Ensure compliance with all serialisation regulatory requirements and manage serialisation data to maintain compliance.
• Support serialisation system validation activities and maintain relevant documentation.
• Support the risk management process through involvement in risk assessment for new (or modified) equipment and new processes.
• In conjunction with Operations lead or support technical, product and process reviews to resolve operational, performance and functional issues.
• Support the implementation of new serialization systems and upgrades to existing ones.
• Ensure all activities undertaken are in accordance with statutory, regulatory and company EHS, cGMP and technical standards, procedures and systems.
• Create and sustain a working environment that promotes the PCI Pharma Services Values and Behaviours.
• To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder's capabilities.

Scope and Authority:

• The job holder is responsible for adhering to the company's SOPs, Health & Safety, cGMP and other regulatory guidelines themselves and for team members and contractors under their control.
• The job holder is responsible for managing and maintaining capital project budgets as and where appropriate.

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled