Process Engineer - R&D
SK biotek Ireland is seeking to recruit a process engineer to join their R&D team on a 1 year fixed term contract.
This is a technical role which will primarily focus on the introduction of new products &
technologies to the Swords site. This challenging but exciting role will cover all parts of the
technical transfer process and will provide a wide breadth of experience in this space, from
assessing suitability and requirements for new processes, through process development and
scale up, to executing clinical and validation campaigns on the plant.
The successful candidate will also provide engineering support to Operations for existing
commercial products, with a focus on troubleshooting and process improvements.
The successful candidate will collaborate closely with both internal stakeholders and customers
involved in the development, manufacture & supply of APIs including EHS, Manufacturing,
Quality, Engineering & Maintenance groups.
Key Responsibilities
- Complete assessments (plant fits) for new products identifying plant suitability and any CapEx requirements.
- Co-ordinate New Product tech transfer activities. Design how new manufacturing processes will be implemented in commercial manufacturing plants. Develop the associated PFDs, batch records, risk assessments for new products.
- Collaborate with R&D Chemistry group on process development and scale up activities
- Provide key process engineering support for commercial products focusing on troubleshooting and optimisation.
- Identify and implement new technologies for the Swords site as required to meet requirements for new products
- Lead process change projects from concept through to implementation & close-out.
- · Actively participate in manufacturing campaign support teams.
- · Support the EHS aspects of new product introduction projects, including HAZOPs, specifying equipment requirements, compatibility assessments, material handling & containment requirements, emission modelling.
- · Lead and support quality and safety investigations.
Education/Experience
- B.E. Chemical Engineering (Masters qualification desirable but not essential)
- 3+ years' experience in the Pharmaceutical industry, preferably small molecule API.
- Strong technical background in Process Engineering and good understanding of pharmaceutical manufacturing.
- Strong interpersonal and communicational skills, as well as excellent problem solving skills and commitment to safety, compliance and continuous improvement.
- Capability to build alignment with business partners and customers including EHS, Quality,
- Operations, Engineering & Maintenance organisations.
- Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments.
- Good working knowledge of Process Analytical Technology (PAT), statistics and modelling is desirable.
