Arcadis DPS Engineering are a seeking a NPI Process Engineer for a Pharmaceutical assignment located in Sligo. This is initially a 12-month contract.
Responsibilities
* Lead and execute process gap analysis, facility fit studies, and process safety/risk assessments (e.g., PFMEA, EHS) for New Product Introductions (NPI).
* Develop and update critical NPI process documentation, including Transfer Plans, Protocols, Procedures, and Manufacturing Batch Records.
* Monitor and analyze process data during manufacturing to ensure robust process performance and compliance.
* Provide operational technical support and problem-solving for process-related issues, ensuring timely resolution.
* Assist in developing and optimizing manufacturing processes for the introduction of new products, collaborating with global science and quality teams.
* Prepare and maintain specifications for NPI materials and consumables to ensure quality and regulatory compliance.
* Lead or assist in product and process-related investigations, change plans, and continuous improvement initiatives.
* Support, supervise, and train operations personnel on NPI processes to ensure capability and compliance.
* Adhere to, promote, and ensure compliance with all EHS&E standards, cGMP, HPRA/FDA regulations, and internal policies.
Requirements
* Bachelor's degree in a relevant engineering, science, or technical discipline (essential).
* Minimum of 1-3 year's experience in a similar process engineering role within pharmaceutical or biopharmaceutical industries.
* Strong technical and operational knowledge of unit operations within a fill-finish facility (essential).
* Proven problem-solving skills, attention to detail, and ability to work autonomously under pressure.
* Excellent communication and interpersonal skills, with demonstrated ability to lead and influence cross-functional teams.
* Experience in new product introduction (NPI), technical transfers, and/or scale-up activities in a cGMP environment (desirable).
Why Join Arcadis?
At Arcadis, we empower individuals to excel because your contributions matter. Taking a skills-based approach, we provide opportunities for you to shape your career, maximize your impact, and grow professionally. By joining us, you'll engage in meaningful work that drives sustainable solutions for a better planet while leaving a lasting legacy.
Our Commitment to Equality, Diversity, and Inclusion
We are dedicated to creating an environment where everyone can thrive. Through our six ED&I workstreams—Age, Disability, Faith, Gender, LGBT+, and Race—we foster innovation by bringing together diverse perspectives. Together, we strive to improve quality of life while building a more inclusive future.