Description

Who We Are

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

SUMMARY

This position is responsible for planning and scheduling of Facilities Calibration and Maintenance work orders in a cGMP regulated environment.

This position communicates and coordinates with multiple departments and outside vendors for work involving instrument maintenance across multiple facilities. It requires high accuracy and diligence to avoid impact on compliance, equipment reliability, and manufacturing uptime.

RESPONSIBILITIES

· Comply with all Company and Department policies and procedures.

· Ownership of Instrumentation calibration and repair work orders in the planning and scheduling phases, tracking progress, and prioritizing to ensure on-time completion.

· Collaborate with Maintenance Repairs to obtain parts, Manufacturing Scheduling for equipment time, Instrumentation, Maintenance Mechanics, Engineering, and Vendors for wrench time, and Contract Associates for Purchase Orders.

· Be the scheduling point of contact with external vendors for on-site work, including obtaining quotes, and tracking requisitions to obtain Purchase Orders for services.

· Ownership of related Preventative Maintenance (PM) schedule master data, including labor estimates and due dates, keeping them optimized and maintained. Assist with development and review of PM tasks, checklists, and job plans. Collaborate with Technical Writers and CMMS Administrators for updates.

· Ownership of work order cycle times to ensure movement through their life cycle phases in a timely manner. Daily monitoring of work orders for due date risk and initiating extensions as needed. Tracking of daily schedule with the instrumentation team.

· Prioritize and bulk work based on impact to manufacturing, quality related events, due dates, parts availability, and vendor availability. Work to eliminate excessive downtime to manufacturing.

· Generate unscheduled calibration work orders for instruments as needed.

· Collaborate with Facilities Compliance for impacting calibration work to controlled environments.

· Daily review of shift pass-down and emergency work requests and keep work orders and related departments updated.

· Occasional job walks of field equipment with exposure to operating factory environments.

· Other duties as needed or assigned.

EXPERIENCE

Required Skills:

· Minimum 6+ years field experience in a maintenance environment or calibrating instruments or GxP Manufacturing environment.

· Ability to read and interpret P&ID and other technical drawings like floor plans.

· Experience in a GMP regulated environment (part 11 compliance), pharmaceutical industry and/or clinical research environment.

· Exceptional organizational, communication, and critical thinking skills. Must be detailed oriented and able to keep up with many changes, and multiple priorities.

· Self-motivated individual, able to work well in a team environment. Work with minimal supervision and have a customer service approach.

· Foster and maintain positive relationships with end users, customers, and cross-functional support groups.

· Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point, MS Outlook, SharePoint/O365

Desired Skills:

· Experience with instrumentation and calibration highly desirable.

· Experience with GMP or GLP instrumentation and manufacturing equipment and experience planning and scheduling maintenance or calibration work.

· Position requires working within BioMarin enterprise software systems including, EAM/CMMS, VEEVA, Bio-G, JIRA/SWIM, and Compliance Wire. Experience with one or more of these systems is highly desirable.

· Effectively respond to rapidly changing environments or situations with immediate alternative solutions

· Ability to foresee a future state and implement a successful action plan

· Make effective decisions based on experience and prior knowledge of maintenance and calibration activities.

EDUCATION
· A combination of technical, military, and/or equivalent experience can be used in lieu of degree or Bachelors of Arts/Science Degree (Engineering, Operations, Supply Chain, or Scientific Field)

EQUIPMENT
This position requires the ability to utilize a computer and other office equipment such as a phone/headset, sit/stand desk, chair, keyboard, and mouse.

CONTACTS
There will be extensive contact with staff in Instrumentation, Facility Services, Manufacturing, and Engineering.

SUPERVISOR RESPONSIBILITY
No personnel directly report to this position.

SHIFT DETAILS
This position must be available during regular business hours, Monday through Friday, 8 hours a day. Start time is flexible.

ONSITE, REMOTE, OR FLEXIBLE
This is a flexible style position, requiring 3 on-site days, one of which must be Wednesday, and 2 off-site days.

TRAVEL REQUIRED
No travel is required for this position.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.