NPI Process Engineer

3 weeks ago


Sligo, Ireland Arcadis DPS Full time

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 Bachelors degree in a relevant engineering, science, or technical discipline (essential). Minimum of 1-3 years 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, youll 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 workstreamsAge, Disability, Faith, Gender, LGBT+, and Racewe foster innovation by bringing together diverse perspectives. Together, we strive to improve quality of life while building a more inclusive future.


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