- Develop and optimize primary packaging processes for pharmaceutical products.
- Design, implement, and validate packaging equipment and systems to meet regulatory requirements.
- Collaborate with cross-functional teams to ensure seamless integration of primary packaging processes with manufacturing activities.
- Lead troubleshooting efforts to address packaging process issues and implement corrective actions.
- Conduct risk assessments and develop mitigation strategies to minimize packaging process hazards and ensure product safety.
- Create and maintain documentation related to primary packaging processes, including standard operating procedures and validation reports.
- Provide technical expertise for primary packaging-related regulatory inspections and audits.
- Stay updated on industry trends, guidelines, and best practices related to primary packaging technologies and processes.
- Take responsibility for an assigned process(es) and become the site SME educating and training others. Work with vendors to better understand the technology and seek to 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Drawing & equipment specification data base, this is to include the generation, recording, filing and archiving of withdrawn / superseded Technical Drawings and associated documentation.
- Focus on delivery – Right First Time (RFT) and On Time in Full (OTIF).
- Support the development of PCI internal engineering 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 technologies employed to meet the business objectives.
- Ensure compliance with all primary, secondary and territory packaging tooling ways of working and specifications for the ordering, receipt inspection, storage and control.
- Support the execution of Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for assigned area of expertise.
- Ensure technical engineering documentation is completed in a timely manner as per site procedures supporting Good Engineering Practice (GEP).
- Work in conjunction with Procurement to identify preferred suppliers for engineering services and materials.
- 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.
- 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.
- 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.
Process Engineer, Primary Packaging - Stamullen, Ireland - PCI Pharma Services
Description
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.
Main purpose of job:
Working within the Engineering function for PCI Pharma Services (Ireland Sites) the Process Engineer will act as the Subject Matter Expert (SME) for Primary packaging processes within the technical function of Engineering. The Process Engineer will display strong technical ability and have interpersonal and communication skills that build the strongest of relationships at department and site level.
The process engineer will be responsible for overseeing the primary packaging processes equipment used in pharmaceutical manufacturing. This individual will play a key role in ensuring the quality, efficiency, and compliance of primary packaging operations.
Main responsibilities:
Responsible for process engineering within PCI's Ireland operations including:
Scope and Authority:
It is a requirement of this role that on occasion the individual will be required to travel on company business. This may be vendor/supplier or customer based.
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Join us and be part of building the bridge between life changing therapies and patients.