Process Engineer (Sterile Filling)
The Process Engineer provides technical support and expertise in the build-out, equipment procurement, commissioning, validation, and tech-transfer activities associated with the start-up of the new Aerie Ireland manufacturing facility. For the on-going commercial operation of the facility, the Process Engineer will provide key technical support in the areas of process control, manufacturing process troubleshooting, process optimization, process development, and product transfer. The Process Engineer will report to the Technical Services Manager.
Essential Duties, Functions 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.
- Will program manage and technically lead receiving site activities necessary for the successful transfer of new products onto the Athlone site via a structured and compliant NPI (new product introduction) process.
- Will prepare site process descriptions by developing a PCS (process control strategy) for the processes and in identifying and agreed with Quality the process CPPs (Critical Process Attributes) and CQA (Critical Quality Attributes) for products.
- Provides technical support for product PPRs (Periodic Product Review)
- Is the process SME for the compounding and filling process and supports manufacturing and maintenance in the operation and maintenance of these systems.
- 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.
- Provides training and mentoring to build technical capabilities among teams.
- Supports capital projects throughout equipment lifecycle.
- Strong technical knowledge of aseptic manufacturing techniques, procedures and theory.
- Knowledge of best practices in pharmaceutical product development, scale-up and technology transfer.
- Specific knowledge of sterile pharmaceutical manufacturing processes and technologies.
- 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
- Strong team player.
- Good proactive approach & manner
- Bachelors Degree in Mechanical Engineering, Pharmaceutical Sciences, or related Science discipline.
- Further qualification (Masters) in related discipline ideal.
- At least 8 years relevant experience in a pharmaceutical manufacturing environment, with at least 5 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:
- Product introduction and transfer
- Cycle time and yield improvement initiatives
- Continuous improvement projects
- Equipment engineering runs, cycle development, PQ, Eng Runs, Media Fills and PV.
- Regulatory audit preparation and follow-up
- Equipment and component specification
- Component preparation – autoclaves, etc.
- Vial or bottle filling of sterile solutions
- Cleaning (CIP/SIP) and sterilisation technologies
- Isolator technology incl. VHP
- Compounding – dispensing, formulation, sterile filtration, etc.
- Primary container closure components