Company:
A global leader in pharmaceutical and medical device manufacturing, focused on high quality production, innovation, and regulatory compliance. The organization operates in a highly regulated environment with a strong emphasis on automation, safety, and continuous improvement.
Job Description:
The Senior Equipment Engineer plays a key role in leading and executing technical projects that support manufacturing operations, particularly in device assembly, inspection, labeling, and packaging. This position is responsible for managing the full lifecycle of equipment, from design and installation to optimization and maintenance. You will act as the technical lead within project teams, collaborating with internal stakeholders and external vendors to ensure equipment performance, reliability, and compliance with regulatory standards.
Responsibilities:
- Lead technical execution for assigned equipment or process areas within capital and operational projects
- Serve as the main technical liaison between internal teams and equipment vendors
- Translate user and process requirements into detailed technical specifications
- Collaborate with project managers on timelines, risks, and deliverables
- Develop engineering documentation including URS, FDS, HDS, and design reviews
- Coordinate detailed engineering activities and ensure compliance with requirements
- Conduct equipment characterization and performance testing through controlled experiments
- Support factory acceptance testing and site acceptance testing activities
- Oversee installation, commissioning, and validation of equipment systems
- Troubleshoot equipment failures and implement corrective actions
- Drive continuous improvement initiatives to enhance performance, safety, and efficiency
- Support root cause investigations and cross functional problem solving
- Ensure compliance with good manufacturing practices and internal procedures
- Promote a safe working environment aligned with health and safety standards
Requirements:
- Bachelor’s degree or higher in Mechanical Engineering or a related field
- Minimum 6 years of relevant experience, with at least 4 years in manufacturing or operations
- Experience in pharmaceutical, medical device, or automated assembly environments
- Hands on experience with commissioning and equipment validation
- Strong knowledge of equipment design, installation, and maintenance processes
- Experience working in regulated environments such as GMP, OSHA, or EPA
- Strong project management and stakeholder communication skills
- Ability to create detailed engineering documentation and specifications
- Proficiency in Microsoft Office tools
- Fluent in English, both spoken and written
- Willingness to occasionally work outside standard office hours
Other Information:
- Works closely with cross functional engineering, quality, and operations teams
- Involves interaction with external equipment vendors and suppliers
- May require flexibility in working hours depending on project needs
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