Purpose
This role will be part of our operations technical support team, with day-to-day responsibilities in the Manufacturing team in our new state‑of‑the‑art single-use multi-product biotech facility in Dunboyne, County Meath, Ireland. The Shift Engineer will work across the site teams to identify and resolve issues in order to allow the site to deliver on our commitment to support Quality, EHS, technical problem solving and continuous improvement. The Shift Engineer will be responsible for the use of process engineering systems and approaches during processing shifts for monitoring equipment and process performance, being the main point of contact for real‑time process monitoring and troubleshooting, ensuring equipment and process are performing optimally and safely to support production activities, acting as subject‑matter expert (SME) support to deviation investigations, and using risk‑management techniques to prioritize activities and initiatives. Ongoing optimisation of process equipment and development of future breakthrough business solutions will be key focus areas. The role will involve being a key point of contact and liaison between Manufacturing Operations and Manufacturing Technical Support, working as part of a team of scientists, engineers and support specialists who will be responsible for supporting routine batch activities and transforming the business initiatives. The Shift Engineer will be embedded on the manufacturing floor with production personnel during shift operations in order to provide real‑time response to issues and play a key role in the coaching and development of the Manufacturing team.
Responsibilities
Work with the Integrated Process Team (IPT) to ensure the effective and efficient on‑time delivery of batch production within the IPT area.
Support operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. Production Plan, technical support, compliance and team training.
Provide assistance and/or support maintenance, engineering, quality or other colleagues as requested.
Support the execution of engineering, clinical and commercial manufacturing processes according to established work instructions and Standard Operating Procedures.
Liaise with other groups and individuals to ensure planning of tasks is effective and linked into the manufacturing process plan.
Ensure supply of high‑quality product through equipment availability.
Provide technical, process and engineering expertise within a wide range of projects within the IPT.
Maintain a high level of personal expertise and working knowledge of all aspects of the manufacturing process and process equipment through continuous training and development.
Resolve issues and identify risks and escalated in a timely fashion.
Act as a key point of contact for the introduction of new process equipment into the facility, and provide technical support for the operations‑based manufacturing personnel as equipment is brought on line.
Have an in‑depth understanding of specific EBRs in the facility, making technical changes that are required to meet the demands of the business or in response to any requirements for process changes that may occur.
Pull together cross‑functional teams to deliver on deviations, improvements and equipment changes that will move the production processes forward in the facility.
Support/Drive future updates to the batch recipe on the PAS (process automation system), the BOM (bill of materials) and the EBR (electronic batch record) for specific process steps.
Responsible for the generation and approval of GMP documentation to support compliance and regulatory expectations for manufacturing operations: change control management and implementation, closure of significant technical investigations, process improvement opportunity identification through implementation, regulatory licence section authoring through response‑to questions, health authority inspection SME support, and more.
Adhere to Right First‑Time principles.
Maximise team member performance through continuous process improvement initiatives.
Education & Experience
Minimum Level 8 qualification in Science, Engineering or related discipline or equivalent industrial experience.
3–5 years experience in a regulated pharmaceutical manufacturing environment, preferably in technical or operations roles.
Demonstrated knowledge of continuous improvement methodologies and in‑depth understanding of site‑level products and related processes.
Demonstrated collaboration, negotiation & conflict resolution skills.
Excellent communication skills (written and oral).
Demonstrated understanding of continuous/process improvement tools (as defined by the site, e.g. DMAIC, Lean QA, 5S etc).
Exceptional analytical, problem‑solving & root‑cause analysis skills.
Ability to multi‑task and handle tasks with competing priorities effectively.
Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.
Experience with working in a multinational organisation.
Other Job Requirements
This role is a shift‑based role and location of work is onsite.
Required Skills
cGMP Guidelines, Electronic Batch Records, Manufacturing, Manufacturing Engineering, Process Engineering, Process Optimization, Standard Operating Procedure (SOP) Writing, Sterile Manufacturing, Teamwork, Troubleshooting
Preferred Skills
Current Employees apply HERE
Current Contingent Workers apply HERE
Employee Status
Regular
Relocation
No relocation
VISA Sponsorship
No
Travel Requirements
No Travel Required
Flexible Work Arrangements
Not Applicable
Shift
Not Indicated
Valid Driving License
No
Hazardous Material(s)
n/a
Job Posting End Date
04/4/2026
Requisition ID
R389524
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