Website Asset Recruitment
The Process Engineer is responsible for the performance of the process equipment. This Engineer will provide key technical support in the areas of yield improvement, reliability, process control, manufacturing process troubleshooting and product transfer.
• 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.
• Process SME for the new product introduction process and supports manufacturing and maintenance in the operation and maintenance of these systems.
• 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.
• 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.
• Bachelor’s 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.
• 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
• Experience with many of the following processes:
– Vial or bottle filling of sterile solutions o Compounding – dispensing, formulation, sterile filtration, etc.
– Isolator technology incl. VHP
– Cycle time and yield improvement initiatives o 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