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Job Description
Experienced Process Engineer sought for 12-month contract in Kildare, Ireland, to lead projects and develop processes in a highly regulated pharmaceutical environment.
Job Description
STEM Recruitment Partners are working with an engineering consultancy to find a skilled Process Engineer to work with a pharmaceutical company in Kildare. The successful candidate will have a strong background in process engineering and project management, with experience in the pharmaceutical industry.
Key Responsibilities:
- Lead and manage projects for new Oral Solid Dose (OSD) products, equipment, and processes, ensuring compliance with safety, quality, regulatory, and operational standards.
- Conduct process mapping, gap analysis, process development, troubleshooting, and optimization.
- Oversee project management tasks including planning, scheduling, task management, and reporting to deliver projects on time and within budget.
- Manage and execute process and equipment trials and validation.
- Lead cross-functional teams, collaborating with departments such as Production, Quality, Safety, Regulatory Affairs, Facilities, Supply Chain, and Finance.
- Specify, design, procure, install, and validate new equipment.
- Optimize existing processes to meet product output targets.
- Ensure adherence to cGMP through coordinated changes using approved change control procedures.
- Generate, review, and approve project documentation and SOPs.
- Support and participate in validation activities and continuous improvement initiatives.
- Provide technical support for system end users and assist with troubleshooting and process investigations.
- Develop training materials and provide training on new equipment and process functionality.
- Ensure compliance with all safety policies, procedures, and regulations.
Qualifications:
- B.Eng in Chemical and Processing Engineering or a related science or engineering discipline.
- Minimum of 5+ years relevant experience in a process engineering/projects role within the Pharmaceutical, BioPharma, or Chemical industry.
- In-depth understanding of pharmaceutical manufacturing processes, including dry blending, compression, compaction, coating, granulation, containment, and material handling.
- Proven track record in process development, support, and improvement.
- Strong project management skills with the ability to handle multiple tasks to tight schedules.
- Experience in process equipment procurement and validation.
- Excellent communication skills with a creative approach to problem-solving.
- Strong leadership skills with experience leading cross-functional teams.
- Flexibility and adaptability to changing priorities.