About the Role
We are seeking a Process & Technology Engineer to join our team, working closely with Senior Process & Technology Engineers.
Duties and Responsibilities
* Lead process/product validations within the department, in conjunction with Quality/Validation/Operations groups. Prepare associated protocols, develop and execute plans, and compile relevant reports as required.
* Provide day-to-day technical support for processing issues or changes on existing manufacturing processes. Lead and coordinate troubleshooting of various manufacturing process issues using Root Cause Analysis methodology, and implement robust corrective and preventative actions.
* Lead investigations into process, product, and quality issues to achieve long-term solutions. This includes technical support and contact with external Merck personnel and customers on process and product lines.
* Maintain and develop manufacturing process documentation and procedures. All process changes and modifications to be documented and tracked closely.
* Ensure compliance with GMP and Safety requirements on new and existing equipment.
* Lead and co-ordinate Risk Mitigation initiatives such as FMEA and Risk Assessments. Identify and develop risk-based approach to change management in conjunction with validation and QA groups.
* Conduct feasibility trials/process DOE's to determine appropriate/robust process windows.
Requirements
* 3+ years relevant experience, preferably within Medical Device industry or other regulated environments.
* Working knowledge of Product & Process validations essential.
* Excellent verbal, written & interpersonal communication skills.
* Process driven and experienced in standardizing and simplifying work processes.
* Leadership & Influencing Skills.
* Excellent engineering ability.
* Good stakeholder management skills across all levels.
* Experience in working in a complex matrix organization.
* Team Orientated.
* Demonstrate a high level of responsiveness to internal customers (eg. production).
What We Offer
We are a diverse team that values diversity and believes it drives excellence and innovation. We celebrate all dimensions of diversity and believe it strengthens our ability to lead in science and technology. We offer a culture of inclusion and belonging where you can grow and develop at your own pace.