NPI Process Scientist

Dillon Engineering Services; Connacht; On-site; EUR 70,000 - 100,000; Full time

Job summary

The NPI Process Scientist will support the introduction of new products into manufacturing, ensuring robust process development, technology transfer, and operational readiness within a cGMP environment. This role requires close collaboration with global science, quality, and manufacturing teams to deliver compliant, efficient, and high-quality processes, while adhering to EHS and regulatory standards.

You will lead and support risk assessments, transfer plans, batch records, and training of

Qualifications

• Requires third-level qualification in Engineering, Science, or a related technical discipline.
• Minimum 3 years’ experience in pharmaceutical process engineering within a cGMP environment.
• Experience in batch processing, scale-up, and technology transfer activities.
• Minimum 1 year’s experience in a similar role within pharmaceutical or biologics manufacturing.

Responsibilities

• Support development and implementation of manufacturing processes for new product introductions (NPI).
• Provide technical support for process-related issue resolution within manufacturing operations.
• Perform gap analyses, facility fit studies, and process safety and risk assessments.
• Monitor and analyse process performance data during manufacturing campaigns.
• Prepare and update specifications for NPI materials and consumables.
• Lead and/or support risk assessments (e.g. PFMEA, EHS).
• Develop NPI documentation including transfer plans, protocols, procedures, and batch records.
• Collaborate with global science and quality teams to support process development for future products.
• Support and/or lead product and process investigations and change management activities.
• Train and support operations personnel on NPI processes.
• Ensure adherence to all EHS, quality, and compliance standards.

Skills

Problem solving

Communication

Organisational skills

Attention to detail

Results oriented

Education

Bachelor's degree in Engineering, Science or related

Job description

The NPI Process Scientist will support the introduction of new products into manufacturing, ensuring robust process development, technology transfer, and operational readiness. This role requires close collaboration with global science, quality, and manufacturing teams to deliver compliant, efficient, and high-quality processes within a cGMP environment.

Responsibilities

• Support the development and implementation of manufacturing processes for new product introductions (NPI).
• Provide technical support for process-related issue resolution within manufacturing operations.
• Perform gap analyses, facility fit studies, and process safety and risk assessments.
• Monitor and analyse process performance data during manufacturing campaigns.
• Prepare and update specifications for NPI materials and consumables.
• Lead and/or support risk assessments (e.g. PFMEA, EHS).
• Develop NPI documentation including transfer plans, protocols, procedures, and batch records.
• Collaborate with global science and quality teams to support process development for future products.
• Support and/or lead product and process investigations and change management activities.
• Train and support operations personnel on NPI processes.
• Ensure adherence to all EHS, quality, and compliance standards.

Requirements

• Third-level qualification in Engineering, Science, or a related technical discipline.
• Minimum 3 years’ experience in pharmaceutical process engineering within a cGMP environment.
• Experience in batch processing, scale-up, and technology transfer activities.
• Minimum 1 year’s experience in a similar role within pharmaceutical or biologics manufacturing.
• Strong understanding of unit operations within a fill-finish facility.
• Experience supporting new product introductions in biologics manufacturing facilities.
• Strong problem-solving skills with the ability to evaluate multiple technical solutions.
• Innovative mindset with the ability to implement new and effective approaches.
• High attention to detail with a strong focus on compliance and quality.
• Results-driven with the ability to meet targets and performance metrics.
• Excellent communication and interpersonal skills.
• Strong organisational and prioritisation abilities aligned with business needs.
• Demonstrates integrity, accountability, and a strong work ethic.

Ownership & Accountability

• Take ownership of delivering NPI projects and supporting commercial manufacturing campaigns.
• Ensure compliance with cGMP, HPRA, FDA, and internal quality standards.
• Support EHS initiatives and partner with EHS teams on safety-related activities.
• Drive issue resolution through to completion with a "right first time" approach.
• Work independently with a high level of autonomy while aligning with site and corporate objectives.

Leadership & Influence

• Lead and support cross-functional teams and continuous improvement initiatives.
• Provide technical leadership across functional areas and NPI sub-projects.
• Build strong working relationships with MS&T and GPRD teams.
• Contribute to site goals, CJRs, and Technical Operations initiatives.
• Support talent development through mentoring, training, and guidance.

Decision Making

• Provide technical expertise to support daily operations and process decisions.
• Escalate significant decisions to the NPI Technical Manager as required.
• Operates with a high level of autonomy under the guidance of the NPI Technical Manager.
• Provides intermittent supervision and support to junior staff, including ODPs, TDPs, and interns.

EHS Responsibilities

• Comply with all EHS policies, procedures, and best practices.
• Maintain awareness of personal and team safety at all times.
• Report all incidents, near misses, and unsafe conditions via the appropriate systems.
• Support continuous improvement of EHS culture and performance.
• Attend required EHS training and adhere to PPE requirements.

Note: Only candidates with a valid work visa for Ireland or an EU passport will be considered.