Senior Process Engineer

Role Summary:

• A new vacancy for an experienced Process Engineer exists on our clients site based in Co. Westmeath.
• The Process Engineer is responsible for the operation of the process equipment on site.
• The successful candidate will provide technical leadership in the areas of yield improvement, reliability, process control, manufacturing support, manufacturing process troubleshooting and product transfer.
• The Process Engineer will report to the Senior Manager Technical Services.

Core Duties and Responsibilities:

• Has ownership of process equipment line reliability. Ensuring that any process equipment related plant downtime is quickly and reliably resolved in a cGMP compliant manner. Identify the short, medium and/ or long-term fixes for the downtime and manages the implementation of these fixes.
• Pro-actively identify risks to the security of site manufacturing supply. Lead cross functional teams in projects to mitigate these risks.
• 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 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, cycle time improvement and capacity increase.
• Provides technical support for product APRs (Annual Product Review)
• Provides training and mentoring to build technical capabilities among teams.
• Supports capital projects throughout equipment lifecycle.
• 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.
• Can lead multi-discipline teams through complex technical projects, while adhering to a set timeline.
• Ability to co-ordinate projects, in addition to providing technical expertise, specifically:
  • Develop a project scope which includes an assessment of project impacts and required updates to other systems on site.
  • Preparing a schedule with multi-disciplinary input and maintaining that schedule through a project lifetime
  • Delegation of tasks to appropriate departments
  • Co-ordinate all project requirements such as material supplies and identification and management of third-party contractors
  • Handover of project to relevant department with awareness training if required.
  • Ensuring project needs are met from start to finish.
• Strong technical knowledge of aseptic manufacturing techniques, procedures and theory.
• Knowledge of best practices in pharmaceutical product development, scale-up and technology transfer.
• 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, with a proactive approach.
• Strong team player.

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