- A new opportunity has arisen for the role of Process Development Engineer (packaging) at our client’s busy pharmaceutical site in Co. Dublin.
- The successful candidate will report directly to the Manufacturing Operations Manager
- Lead new packaging product introductions on site.
- Be a subject matter expert (SME) for packaging equipment and packaging systems.
- Support primary and secondary packaging operations on site.
Core Duties and Responsibilities:
- New Product Introductions
- Lead Feasibility assessments for new packaging formats and new equipment
- Technical Review of Artwork and Packaging
- Lead optimisation and process validation studies
- Parameter optimisation for vision systems, equipment and serialisation systems
- Understand regulatory requirements and communicate them to the project team
- Lead Capital Projects for equipment introductions as required
- Packaging SME
- Lead Root Cause Analysis for Packaging Processes
- Troubleshooting and maintenance of Serialisation Systems
- Troubleshooting and maintenance of Vision Systems
- Troubleshooting and maintenance of Packaging Equipment
- Operations Support
- Liaise with QC, QA, CAPEX Team, Logistics, Supply Chain and Manufacturing to ensure adherence to schedule and efficient troubleshooting
- Provide technical support and direction to manufacturing personnel in order to ensure that the manufacturing and ancillary facilities can be operated to optimum efficiency and that Plant Turnarounds are executed in an efficient manner.
- Actively participate in problem identification, problem solving and change initiatives in cooperation with other teams and services. Continuous improvement with a cross functional focus is a core activity.
- Investigate quality events as they arise and prepare deviation reports using site Trackwise system.
- Complete required documentation relating to development and manufacturing activities in an accurate and timely manner. Such documentation would include (but not be limited to) BMRs and SOPs.
- General Role Responsibilities:
- Support a culture of open communication, fairness and transparency.
- Available to participate in ‘on call’ program and respond to ‘call out’ as required.
- Participate in any required training and ensure team members are suitably trained.
- Drive a continuous improvement mindset in line with AGILE programme.
- Uphold Company Code of Conduct.
- Ensure that they themselves perform all operations in accordance with site quality standards, GWPs, cGMPs and all other relevant policies, procedures, regulations and standards including Health & Safety and Environmental (HSE) Legislation.
- Foster a safe work environment, ensuring all colleagues maintain safety as a priority.
- Other duties as required and directed by the Manager, Finance or other Officer appointed by the Board of Directors.
Education & Qualifications Required:
- 3rd Level Degree in Engineering or other relevant course.
- Minimum 3 years experience in Pharma Manufacturing
- Experience of Secondary Packaging systems
- Experience of Primary Packaging Systems beneficial
- Experience of Vision Systems
- Experience of Serialisation Systems beneficial
- Excellent written and verbal communication skills
- Flexible, willing and positive attitude / mind-set with an excellent planning, scheduling and prioritisation ability
- Excellent documentation skills and attention to detail; strong Quality orientation.
- Excellent knowledge of Microsoft products and systems skills.
- Ability to work under pressure & managing conflicting tasks at the same time.
- Ability to work well with others to achieve organisational goals.
- Safety focused.
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100
Please note, we do not require agency assistance with this role.