Negotiable
Undetermined
Undetermined
Location Leiden, South Holland, Netherlands
Summary: The Calibration Technician role focuses on maintaining and improving equipment critical for the manufacturing and measurement of medical devices. The position involves performing calibrations, documenting processes, and suggesting improvements to calibration methods. Candidates are expected to have a strong technical background and excellent communication skills to effectively collaborate with internal and external stakeholders. This role is essential for ensuring compliance with industry standards and enhancing operational efficiency.
Key Responsibilities:
- Maintain and improve the status of key equipment and components for manufacturing and measurement.
- Perform scheduled routine and nonscheduled calibrations on production and facilities equipment.
- Document and review work performed as per company procedures and applicable regulations.
- Suggest and develop improvements to existing calibration methods and systems.
- Increase knowledge of the manufacturing process and equipment to identify calibration needs.
- Maintain calibration status of all measuring and critical manufacturing equipment.
- Assist in establishing calibration and test methods for new and existing equipment.
- Accurately complete all calibration test records and ensure calibration records are updated and easily retrievable.
- Raise issues and report on calibration failures.
- Develop and revise standard operating procedures (SOPs) for calibration of new and existing equipment.
- Engage in projects, programs, committees, and special activities to promote the company's strategic goals.
- Attend relevant training programs and notify supervisors of any tasks or responsibilities that require additional training.
- Perform other tasks assigned by the supervisor as needed.
Key Skills:
- Associate Degree in Industrial, Electrical, Instrumentation, Mechanical Electronics, or related field.
- Professional certifications as required by regulation.
- Excellent verbal and written communication skills.
- Proficiency in MS Office and SAP.
- Ability to identify gaps, root causes of issues, and think creatively to develop solutions.
- Ability to work independently with minimal supervision.
- Strong technical skills in pharmaceutical production equipment.
- Ability to read mechanical drawings, electrical schematics, and drawings.
- Demonstrated skills in root cause analysis and problem-solving.
- Proficiency in automation (depending on functional area).
- Good knowledge of compliance with Occupational Safety, Environment, and Good Manufacturing Practices (cGMPs).
- Basic knowledge in aseptic techniques.
- Good documentation and verbal communication skills.
- Basic knowledge in the use of computer systems preferred.
- Willingness to work rotating shifts, overtime, holidays, and weekends.
Salary (Rate): undetermined
City: Leiden
Country: Netherlands
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Are you passionate about maintaining and improving equipment essential for manufacturing and measuring medical devices? Join our team and make a significant impact on our operations!
Essential Job Duties and Responsibilities
- Equipment Maintenance: Maintain and improve the status of key equipment and components for manufacturing and measurement.
- Calibration: Perform scheduled routine and nonscheduled calibrations on production and facilities equipment. Handle OOS situations and inform QA through Calibration Alerts.
- Documentation: Document and review work performed as per company procedures and applicable regulations.
- Process Improvement: Suggest and develop improvements to existing calibration methods and systems.
- Knowledge Development: Increase knowledge of the manufacturing process and equipment to identify calibration needs.
- Status Maintenance: Maintain calibration status of all measuring and critical manufacturing equipment.
- Method Establishment: Assist in establishing calibration and test methods for new and existing equipment.
- Record Keeping: Accurately complete all calibration test records and ensure calibration records are updated and easily retrievable.
- Issue Reporting: Raise issues and report on calibration failures.
- SOP Development: Develop and revise standard operating procedures (SOPs) for calibration of new and existing equipment.
- Participation: Engage in projects, programs, committees, and special activities to promote the company's strategic goals.
- Training: Attend relevant training programs and notify supervisors of any tasks or responsibilities that require additional training.
- Other Duties: Perform other tasks assigned by the supervisor as needed.
Minimum Qualifications
- Education: Associate Degree in Industrial, Electrical, Instrumentation, Mechanical Electronics, or related field.
- Certifications: Professional certifications as required by regulation.
- Communication Skills: Excellent verbal and written communication skills, including the ability to effectively communicate with internal and external customers.
- Computer Proficiency: Proficiency in MS Office and SAP.
- Analytical Skills: Ability to identify gaps, root causes of issues, and think creatively to develop solutions.
- Independence: Ability to work independently with minimal supervision, meet tight deadlines, and maintain a positive attitude.
Other Requirements
- Technical Skills: Strong technical skills in pharmaceutical production equipment.
- Reading Proficiency: Ability to read mechanical drawings, electrical schematics, and drawings.
- Problem-Solving: Demonstrated skills in root cause analysis and problem-solving.
- Automation: Proficiency in automation (depending on functional area).
- Compliance Knowledge: Good knowledge of compliance with Occupational Safety, Environment, and Good Manufacturing Practices (cGMPs).
- Aseptic Techniques: Basic knowledge in aseptic techniques.
- Documentation: Good documentation and verbal communication skills.
- Computer Systems: Basic knowledge in the use of computer systems preferred.
- Availability: Willingness to work rotating shifts, overtime, holidays, and weekends.
