Senior Project Engineer, cGMP Process Equipment

Principal Project Engineer - cGMP Process Equipment

Location: Castleknock, Dublin

We are seeking a highly skilled Principal Project Engineer to join our team in Castleknock, Dublin. This role is responsible for the design, specification, and implementation of cGMP process equipment, piping, and controls within a regulated pharmaceutical or biopharmaceutical manufacturing environment.

Key Responsibilities:

•Lead the design, specification, and procurement of cGMP process equipment, piping, and control systems, ensuring compliance with regulatory and operational requirements.

•Develop and review Piping & Instrumentation Diagrams (P&IDs) and process flow diagrams (PFDs) to ensure system functionality and efficiency.

•Provide technical leadership on project execution, including vendor selection, equipment integration, installation, commissioning, and qualification.

•Collaborate with cross-functional teams, including process engineers, automation specialists, quality assurance, and validation teams, to deliver project milestones.

•Ensure that all engineering work adheres to cGMP, FDA, EMA, and other regulatory standards, as well as internal company policies.

•Identify and mitigate technical risks related to equipment and process design, ensuring operational reliability and efficiency.

•Prepare and review technical documentation, including specifications, risk assessments, and validation protocols (IQ/OQ/PQ).

•Support troubleshooting and optimization of existing process equipment to improve performance and compliance.

Qualifications & Experience:

•Bachelor's degree (BS/BEng) in chemical, process, or mechanical engineering.

•Eight or more years of experience in a related role within the pharmaceutical, biopharmaceutical, or regulated manufacturing industry.

•Strong understanding of cGMP, process design principles, equipment selection, and system integration.

•Experience with automation and control systems for process equipment.

•Demonstrated ability to manage complex engineering projects from concept to completion.

•Strong problem-solving skills and ability to work in a fast-paced, regulatory-driven environment.

We are an equal opportunity employer and value diversity in our workforce. We encourage applications from candidates of all backgrounds, regardless of race, gender, age, disability, or any other protected characteristic. Our commitment is to foster an inclusive and supportive workplace where all employees can thrive.

Apply today to register here on back4good.ie and we will take it from there for you .