Process Engineer

Sterling Engineering Ltd - Ireland & Europe; Sligo; On-site; EUR 60,000 - 85,000; Full time

Job summary

Sterling Engineering Ltd - Ireland & Europe is seeking an experienced NPI / DP Process Engineer to support the introduction of new products into pharmaceutical manufacturing operations. The role focuses on process development, technical transfer, scale-up, risk assessment and ongoing technical support within a cGMP environment.

You will collaborate with cross-functional teams to ensure safe, efficient product introductions compliant with quality, regulatory and EHS requirements.

Qualifications

• A third-level degree in Engineering, Science or a related technical discipline.
• At least one year of experience in a similar role.
• Experience within the pharmaceutical or biopharmaceutical industry.
• Strong technical knowledge of DP fill-finish unit operations.

Responsibilities

• Conduct gap analyses and facility fit studies for NPI.
• Monitor process data to assess performance and identify improvements.
• Develop, optimise and implement DP processes for new products.
• Provide technical support to resolve process-related issues during manufacturing.
• Lead PFMEA and EHS assessments.
• Develop technology transfer plans and batch records.
• Collaborate with global teams on process development and product introduction.
• Lead investigations and change controls; support manufacturing improvements.
• Provide training to operations personnel involved in NPI processes.
• Ensure compliance with cGMP and EHS standards.

Skills

NPI process development

Tech transfer

cGMP compliance

Risk assessment

PFMEA

Data analysis

Education

Bachelor's degree in Engineering or Science

Master's degree (Desirable)

Job description

We are seeking an experienced NPI / DP Process Engineer to support the introduction of new products into our clients pharmaceutical manufacturing operations. This role will focus on process development, technical transfer, scale-up, risk assessment and ongoing technical support within a cGMP-regulated environment.

The successful candidate will work closely with cross-functional teams to ensure new products and processes are introduced safely, efficiently and in compliance with quality, regulatory and EHS requirements.

Key Responsibilities

• Conduct gap analyses, facility fit studies, process safety assessments and risk analyses to support New Product Introduction (NPI).
• Monitor and analyse manufacturing process data to assess process performance and identify opportunities for improvement.
• Support the development, optimisation and implementation of manufacturing processes for new products.
• Provide technical and operational support to resolve process-related issues during manufacturing.
• Prepare, review and maintain specifications for NPI materials and consumables.
• Lead and support risk assessments, including Process Failure Mode and Effects Analysis (PFMEA) and Environmental, Health and Safety (EHS) assessments.
• Develop and maintain NPI documentation, including technology transfer plans, protocols, procedures and manufacturing batch records.
• Collaborate with global scientific, technical and quality teams to support process development and the introduction of future products.
• Lead and support product- and process-related investigations, change controls and improvement plans.
• Provide technical guidance, supervision and training to operations personnel involved in NPI processes.
• Ensure compliance with cGMP requirements and all applicable EHS standards, procedures and policies.

Essential Requirements

• A third-level degree in Engineering, Science or a related technical discipline.
• At least one year of experience in a similar role.
• At least one year of experience within the pharmaceutical or biopharmaceutical industry.
• Strong technical and operational knowledge of unit operations within a drug product (DP) fill-finish facility.

Desirable Requirements

• A Master's qualification in a relevant technical discipline.
• Approximately three years' experience in pharmaceutical process engineering, including batch processing, technical transfer and scale-up within a cGMP pharmaceutical or biologics environment.
• Experience supporting New Product Introduction within biologics manufacturing facilities.
• Knowledge of process development, risk assessment, technical documentation and manufacturing investigations.