- A new opportunity has arisen for an experienced Process Engineer at our client’s pharmaceutical site in Athlone, Co. Westmeath.
- The successful candidate is responsible for the performance of the process equipment on site.
- The Process Engineer will provide key technical support in the areas of yield improvement, reliability, process control, manufacturing process troubleshooting and product transfer.
Core Duties and Responsibilities:
- Works with manufacturing and quality colleagues as part of an Operations team whose shared goal is to realise the safety, quality, delivery and cost objectives of the site.
- Prioritises safety and is diligent in the use of all appropriate safety tools and permits when maintaining equipment – champions safe working always.
- Is the process SME for the new product introduction process and supports manufacturing and maintenance in the operation and maintenance of these systems.
- Is the process SME for the products, supporting or leading product related deviations, change controls and CAPAs.
- Supports manufacturing by leading/supporting deviation investigations, and is familiar with structured problem solving and root cause analysis.
- Supports validation activity in process manufacturing areas.
- Leads continuous improvement projects and initiatives and is owner of yield performance and cycle time improvement.
- Is the process equipment SME, supporting batch manufacturing activities.
- Responsible for managing the introduction of new consumable materials into the GMP cleanrooms.
- Provides technical support for product APRs (Annual Product Review).
- Provides training and mentoring to build technical capabilities among teams.
- The role will typically require infrequent, off site national and international travel, for business or equipment/project review meetings, including overnight stays, up to 10% of the time.
Minimum Qualifications and Experience:
- Bachelors Degree in Engineering, Pharmaceutical Sciences, or related Science discipline.
- Further qualification (Masters) in related discipline ideal.
- At least 5 years relevant experience in a pharmaceutical manufacturing environment, with at least 3 years experience in a comparable process engineering/technical services role.
- Must have experience working in a sterile manufacturing environment.
- Ophthalmic manufacturing experience a plus.
- Experience with many of the following processes:
- Vial or bottle filling of sterile solutions
- Compounding – dispensing, formulation, sterile filtration, etc.
- Isolator technology incl. VHP
- Cycle time and yield improvement initiatives
- Continuous improvement projects
- Regulatory audit preparation and follow-up
- Cleaning (CIP/SIP) and sterilisation technologies
- Component preparation – autoclaves and parts washers.
- Primary container closure components
- Specific knowledge of sterile pharmaceutical manufacturing processes and technologies. Ideally, aseptic filling operations.
- Strong technical knowledge of aseptic manufacturing techniques, procedures and theory.
- Strong analytical skills, documentation skills and research skills.
- Very strong problem-solving skills, ideally using formal tools e.g. FMEA.
- Strong understanding of pharmaceutical industry regulatory requirements.
- Clear understanding of the needs of cGMP and validation (DQ-PQ).
- DoE knowledge desirable.
- Knowledge of sterilization principles and practices
- Strong communication and interpersonal skills. Highly motivated with ability to work effectively with multidisciplinary teams or independently
- Can operate with low levels of supervision
- Strong team player, with a good proactive approach & manner
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.