Overview
Work Your Magic with us
Ready to explore, break barriers, and discover more?
We know you've got big plans – so do we
Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics.
Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet.
We are always looking for curious minds that see themselves imagining the unimaginable with us.
The Role
Reporting to the Principal Process Engineer, the Senior Process Engineer is primarily responsible for supporting day-to-day production within the Biotools manufacturing areas and effectively implementing change management projects.
Responsibilities
Provide day-to-day technical support for processing issues or changes on existing manufacturing processes.
Lead and coordinate the 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.
Identify and lead the implementation of process improvement activities with the cross-functional team based on manufacturing data such as OEE, yield, etc.
Conduct feasibility trials/DOEs to determine appropriate and robust process windows.
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.
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 coordinate risk mitigation initiatives such as FMEA and Risk Assessments.
Identify and develop a risk-based approach to change management in conjunction with QA groups.
Working knowledge of the following would be an advantage but not a requirement: Automated/Semi-Automated assembly equipment; Injection moulding and mould tools; High precision punch & die sets; Heat sealing, ultrasonic welding, leak testing, vision systems; OEE line performance methodology; Minitab/Lean Six Sigma techniques; AutoCAD.
Qualifications
Bachelor's degree in Mechanical/Biomedical/Process Engineering or similar
5 years engineering experience, preferably within Medical Device industry or other regulated environments.
Candidates with less than 5 years experience may be considered but may not be hired in a senior role
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 oriented
Demonstrate a high level of responsiveness to internal customers (e.g. production)
What we offer
We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity.
We believe that it drives excellence, innovation, and human progress.
We care about our customers, patients, and our rich mix of people.
This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions.
Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life
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