Senior Maintenance Specialist

Role Summary

Senior Maintenance Specialist reports to the Director of Manufacturing Engineering. This position is responsible for assisting in the implementation and management of the preventative maintenance and calibration systems at the site.

Responsibilities

• Managing and implementing the site preventive maintenance program and the site calibration program.
• Assist maintenance staff in troubleshooting difficult problems or equipment failures to help reduce equipment downtimes and help train and build a strong maintenance staff resulting in a reduction of equipment failures and expenses.
• Assist in the development of future plant expansion validation and commissioning protocols. Will work directly with engineering and contractors in these upcoming plant renovations.
• Responsible for procuring and directing outside contractors for specialized activities such as validation, calibrations, filter certifications and lab instrumentation certifications and responsible for training on all applicable SOP’s per Quality Assurance guidelines.
• Work with maintenance and engineering to develop systems aimed at lowering operating costs and reducing risks or equipment failures.
• Be a key administrator for the building management system at the facility.
• Follow the occupational safety and health programs including lock out tag out, confined space and fall protection.
• Assist maintenance staff in maintenance activities as necessary and assist production staff with process equipment as necessary.

Qualifications

• Required: Education: High School Diploma/GED
• Required: 5 years of experience in cGMP or cGXP at an operational level supporting manufacturing in a pharmaceutical or biotech environment.
• Required: Knowledge of pharmaceutical cGMPs (US and EU).
• Required: Excellent verbal, written, interpersonal, and organizational and communication skills.
• Preferred: BA or BS degree in a scientific discipline, related field, or comparable experience.
• Preferred: Experience with commercial drug manufacturing.

Education

• High School Diploma/GED

Additional Requirements

• Location: Elwood, Kansas