Job Opportunity: Manufacturing Engineer (Contract Role)
Collins McNicholas is seeking a skilled and motivated Manufacturing Engineer to join our high-performing team involved in a large-scale rebranding project based in Athlone. This role plays a critical part in supporting revalidation efforts related to medical device manufacturing, with a particular focus on change management, equipment processes, and risk management.
Key Responsibilities
* Lead and support validation activities as part of a rebranding project, including updates to labelling and associated documentation.
* Execute equipment and process validations in a regulated medical device environment.
* Conduct and document change management activities, including ECOs and QCOs.
* Collaborate with cross-functional teams to implement revalidation strategies aligned with quality and regulatory standards.
* Review and update test methods and support test method validations.
* Apply statistical analysis tools (e.g., Minitab) to validation and process improvement efforts.
* Prepare and maintain technical documentation in compliance with internal and external standards.
* Perform risk assessments and ensure integration of risk management throughout the validation lifecycle.
* Support audits and inspections by providing relevant validation documentation and insights.
* Share knowledge and mentor team members on best practices in medical device validation.
Requirements
* Bachelor's Degree (Level 8) in Engineering or a related discipline.
* A minimum of 35 years of experience in a validation engineering role.
* Strong background in medical device manufacturing (non-negotiable).
* Demonstrated expertise in equipment and process validations.
* Proficient in change management systems, including ECOs and QCOs.
* Experience with test method development and validation.
* Solid understanding of risk management principles and practices.
* Strong statistical analysis skills; familiarity with Minitab is essential.
* Excellent documentation and communication skills.
* Ability to work independently with minimal supervision, while also contributing to a collaborative team.