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Process Engineer

Location
Athlone, County Westmeath
Job Type
Contract
Posted
8 Sep 2022
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
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Details

  • Job Reference: 707250939-2
  • Date Posted: 8 September 2022
  • Recruiter: PROCHEM Engineering Ltd
    PROCHEM Engineering Ltd
  • Location: Athlone, County Westmeath
  • Salary: On Application
  • Sector: Engineering
  • Job Type: Contract