Process Engineer, Packaging Processes

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 Engineer, Packaging Processes (permanent role) to join our team. This is a Monday to Friday position, 100% on-site.

Main purpose of job

Working within the Engineering function for PCI Pharma Services (Ireland Sites) the Process Engineer, Packaging Processes will act as the Subject Matter Expert (SME) for assigned packaging processes within the technical function of Engineering. The Packaging 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, Packaging Processes will have a proven track record in troubleshooting equipment issues and be capable of understanding and optimising machine performance, be strong in a team environment and possess excellent coordination skills.

Key Responsibilities

Responsible for process engineering within PCI's Ireland operations including:

• Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
• Responsible for process engineering within PCI's Ireland operations including:
• Take responsibility for assigned packaging process(es) and become the site SME educating and training others. Work with vendors to better understand the technology and seek to optimize it's capability to benefit site and customer projects.
• Analyze process data for 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Drawing & equipment specification data base, this is to include the generation, recording, filing and archiving of withdrawn / superseded Technical Drawings and associated documentation.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 labelling, secondary and tertiary 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.
• Support the execution of Qualification and Validation activities involving implementation of new equipment and/or new components.
• Support troubleshooting of packaging process deviations and events, conducting root cause analyses to address quality and performance issues, and leading implementation of corrective and preventive actions (CAPAs and Action Items) applied to the process.
• 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, perform product and process reviews to resolve operational, performance and functional issues.
• Monitoring of future technologies and market trends identifying areas for potential investment in new technologies including reporting and recommendations to the Engineering management team.
• Identification of future CapEx projects to improve the business offerings and competitive edge.
• 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 Behaviors.
• Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
  
  

Essential

Knowledge / Skills & Experience

• Educated to EQF (European Qualifications Framework) level 6 in a Technical, Engineering or a Science subject OR significant experience in industry.
• Min 2 years' experience of engineering within a pharmaceutical facility relating to labelling and packaging process.
• Knowledge of pharmaceutical packaging equipment, packaging materials, technologies and challenges with each.
• Detailed understanding of facility and engineering issues and processes.
• Experience in a GMP or Regulated Environment.
• Proficient utilisation of software packages such as Excel, Word, PowerPoint, Project and Visio and a high level of computer literacy.
• Ability to manage multiple tasks and set priorities.
• Problem Solving and Troubleshooting skills. The successful candidate should display a dynamic and proactive approach to manage problems.
• Self-motivated with a results driven approach.
• Adaptable and ability to work collaboratively.
• Effective communication - internal and external.
• Team working - display obvious signs of ability to work in high performing complex teams.
• Mentoring and coaching - Able to act as a coach and mentor to others.
• Analytical and data-driven
• Attention to detail and persistence.
• Customer centric.
• Committed to the highest levels of integrity, ethics and professionalism
  
  

Desirable

• Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.
• Master's degree in a Technical, Engineering or a Science subject.
  
  

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future

Equal 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.


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