- Responsible of taking a leadership role in the day to day activities of the Maintenance Operations (Planning, Scheduling, MRO).
- Responsible for the planning, scheduling and performance of the maintenance program.
- Responsible for the oversight of BlueMountain Regulatory Asset Manager (CCMS/CMMS) across multiple facilities.
- Responsible to conduct field walk downs to identify and document job requirements.
- Responsible to make available permits and safety procedures required for the job execution.
- Procurement of equipment and specialized tools required to perform the work.
- Responsible to evaluate the need for replacement parts required to perform the work.
- Estimate required hours on work order tasks, total work order duration and skills required to perform the task.
- Responsible to work in conjunction with maintenance supervisors the schedule of staff for the execution of maintenance activities.
- Responsible to maintain equipment bill of materials to cover planned maintenance activities.
- Communicate with technical trades regarding ideas and procedures that would make future jobs more efficient.
- Meet with internal customers in order to plan and schedule calibration and maintenance activities for their instrumentation and equipment across multiple facilities.
- Maintain work load balance across the Metrology and Maintenance Departments and monitors department labor utilization.
- Support other team members and system users on issues pertaining to the CCMS/CMMS system.
- Work directly with Manufacturing, Validation, Quality Assurance, Metrology, Maintenance, Facilities, and Quality Control in order to support their individual department needs.
- Responsible for developing, writing, editing and/or reviewing SOPs for the maintenance operations.
- Monitor departmental KPIs in order ensure a high level of efficiency.
- Be able to handle multiple priorities quickly and efficiently, and delegate tasks to appropriate trades and skill levels.
- Demonstrate continuous personal pursuit to increasing job knowledge, proficiency in technical understanding, and problem solving abilities.
- Maintain a positive, professional, and customer oriented attitude.
Required Skills & Abilities:
- Knowledge of a wide variety of typical maintenance tasks, including PM, spare parts, work order lifecycle and troubleshooting systemic problems. General principles of engineering, operations and the tools and equipment required to perform many of the daily maintenance tasks.
- Strong knowledge of Computerized Calibration & Maintenance Management Systems (CCMS/CMMS), preferably BlueMountain RAM.
- Strong leadership skills, written and verbal communications skills, be self-motivated and possess interpersonal skills.
- Ability to learn quickly and work effectively with little supervision when needed.
- Strong analytical and problem solving skills and experience applying these skills to resolve technical problems.
- Ability to coordinate, facilitate and organize resources in an efficient manner.
- Ability to work effectively under extreme pressure to meet deadlines.
- Well organized and detail oriented with ability to handle multiple activities simultaneously.
- Desire to work in a fast paced, state of the art, alternately research and customized manufacturing facility.
- Working knowledge of MS Office products (Word, Excel, Outlook, and PowerPoint).
- Knowledge of cGMP and cGDP requirements and procedures.
- This role will require a high level of personal organizational skills, experience and drive.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged sitting, standing, walking, bending, stooping and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate portable tools, as well as a computer keyboard, telephone, calculator, and other office equipment is required.
- Have a normal range of vision.
- May be required to lift up to 50 pounds on occasion.
- Climb ladders and stairs of various heights.
- Be exposed to wet or humid conditions.
- This position may include On-Call response for Facility issues.
- Be exposed to outdoor weather conditions.
- Be exposed to noisy environments.
- Attendance is mandatory
- Bachelor’s degree in a related discipline with a minimum of 3 years of overall experience on which at least 2 year must be in a cGMP or other FDA regulated operation; OR
- Associate’s degree in a related discipline with a minimum of 5 years of overall experience on which at least 3 year must be in a cGMP or other FDA regulated operation; OR
- High School Diploma with some additional technical education or training in a college or university with a minimum of 7 years of overall experience on which at least 4 years must be in a cGMP or other FDA regulated operation.
- Experience working in a biotechnology facility is preferred.
- Experience in Start-Up & Commissioning of cGMP Facility.
We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.
If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3528.