Process Engineer

Salary: £54,216 – £81,324 per year

Role Summary:

• 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), as well as 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 and 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. and a 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

To Apply:

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

Please note, we do not require agency assistance with this role.