We are seeking a skilled Manufacturing Specialist to join our team in Carlow.
This role offers the chance to support new product introduction (NPI) and commercial manufacturing while contributing to continuous improvement initiatives in a dynamic environment.
This position is ideal for a motivated individual with experience in manufacturing—preferably in a GMP setting—and a passion for innovation and problem-solving.
Key Responsibilities:
* Support NPI and Commercial Manufacturing: Provide technical support for new product introduction and commercial manufacturing processes.
* Design and Execute Qualification/Validation Documentation: Design, review, and execute qualification/validation documentation and process development studies.
* Lead Change Control Activities: Lead and contribute to change control activities and Kaizen events.
* Analyze Root Causes and Drive Continuous Improvement: Conduct root cause analysis and support continuous improvement initiatives through Lean Six Sigma methodologies.
* Validate Equipment and Processes: Execute equipment and process validation, including re-qualification and re-validation.
* Author Quality Notifications: Provide technical input into quality notifications by authoring, reviewing, and approving investigations.
* Represent the Team: Act as a technical representative in both local and global technical forums.
* Evaluate Compliance: Ensure compliance with cGMP, internal policies, and regulatory requirements.
In this role, you will have the opportunity to work on exciting projects, collaborate with experienced professionals, and develop your skills in a fast-paced environment.
Requirements:
* Bachelor's Degree: Bachelor's Degree (or higher) in Science, Engineering, or another relevant technical discipline.
* Manufacturing Experience: Minimum of 3 years' experience in manufacturing; GMP experience highly advantageous.
* Leadership Skills: Proven ability to lead technical projects and drive results.
* Technical Knowledge: Knowledge of process monitoring systems, automation systems (DeltaV), and data/operational intelligence systems (Pi System) is desirable but not essential.
You will be working in a hybrid environment, with occasional shift support required based on program needs.