Process Engineer – Sterile

This is an exciting role for an ambitious Process Engineer to join a new sterile fill finish manufacturing site as it prepares to commence commercial supply to patients. The successful candidate will be an important member of the site’s Technical Services team who provide technical support to Manufacturing across the manufacturing platforms of component preparation, product compounding, sterile fill and secondary packaging. The Process Engineer will be responsible for equipment and process performance including monitoring performance and developing and implementing continuous improvement initiatives. The Process Engineer will also play a key role in process development and clinical manufacturing programs.  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.
  • Technical owner for manufacturing equipment and processes.
  • Monitors the performance of equipment and processes and, liaising with maintenance colleagues, sets out the continuous improvement activity to enhance the performance of these processes.
  • Supports manufacturing activity through investigation of technical faults through structured and disciplined problem solving.
  • Develops and enhances the PCS (process control strategy) for the processes and monitors process CPPs (Critical Process Attributes) and CQA (Critical Quality Attributes).
  • Provides technical support for product PPRs (Periodic Product Review).
  • Supports validation activity in process manufacturing areas.
  • Works proactively with Automation and IT colleagues to ensure optimum performance of The Client’s processing systems.
  • Builds and delivers detailed technical training programs for the equipment and processes for manufacturing, maintenance and quality colleagues to build technical understanding across the broader site team.
  • Working with colleagues in the Technical Services team is central to the design and execution of The Client process development trials and the manufacturing of clinical trial product where required.
  • Supports capital projects throughout the equipment lifecycle – usually as the system owner from a technical perspective.

Skills/Knowledge Required:

  • Strong technical knowledge of aseptic manufacturing techniques and/or product compounding.
  • Knowledge of best practices in pharmaceutical process development, scale-up and technology transfer.
  • Strong engineering competencies including experience and demonstrated performance across areas including:
    • GMP documentation
    • Project Management
    • Problem Solving
  • Understands pharmaceutical industry regulatory requirements including the requirements of cGMP and validation.
  • Understands cleaning in place (CIP) and sterilisation in place (SIP) theory and systems.
  • Ideally has experience of statistical process control with respect to problem solving and process performance management.
  • Strong communication and interpersonal skills. Highly motivated with ability to work effectively with multidisciplinary teams or independently.
  • Strong team player with proactive approach & manner.

Education Required:

  • Bachelor’s Degree in Engineering, Pharmaceutical Sciences, or related Science discipline.

Experience Required:

  • 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.
  • Ideally has experience working in a sterile manufacturing environment.
  • Experience with many of the following processes:
    • Cycle time and yield improvement initiatives
    • Continuous improvement projects
    • Regulatory audit support
    • 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

For more information please call me on 087 9728431/091555030 or

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