Senior Maintenance Mechanic (Gene Therapy) Details

Senior Maintenance Mechanic (Gene Therapy)

Biogen - Research Triangle Park, NC

Employment Type : Full-Time

Job Description

About This Role

Due to continued growth and the introduction of new technologies across the site, we are looking for a qualified candidate to support the Maintenance Dept. in a GMP and Non-GMP environment. In this role you will be responsible for performing corrective and preventative maintenance on manufacturing, laboratory analytical, and clean and Black utility equipment as well as supporting manufacturing and laboratory personnel in the use, maintenance, and repair of on-site equipment.

What You’ll Do

• Operate, troubleshoot, and repair utility systems which may include Water for Injection, Reverse Osmosis De Ionization, Chillers, Clean Steam Generators, Autoclaves, Glasswashers, Production Vessels, plant steam/condensate, wastewater treatment, Biowaste, Clean Gasses, Filler/Isolator.
• Coordinates on-site and off-site vendor/contractor actions related to the maintenance and repair of critical and non-critical equipment
• Author changes to procedures, maintenance, and job plans
• Coordinates installations of new equipment and parts
• Provides engineering & validation support, Applicants will become trained and skilled in all unit operations in their area and performs most functions with minimal supervision
• Investigates problematic equipment failures
• Site (SME) subject matter expert on validated and non-validated production equipment and utilities. Understands operation of site equipment and systems and how they impact customers as well as site processes
• Provide detailed documentation of all activities using Work Order’s Logs using Info/Enterprise asset management
• Follow Standard Operating Procedures, Piping & Instrumentation Diagrams, job plans and/or equipment manuals to perform work
• Continuously develop knowledge and skills to remain a subject matter expert in your field

Who You Are?

• The ideal candidate for this role is a self-motivated problem solver that is detail orientated with excellent documentation skills. You should enjoy working in a cross-functional environment with different challenges to solve each day.

Required Qualifications

• High School Diploma and min. 10 years’ experience in operations and maintenance, or an AA/AS Degree with an emphasis in an engineering/technical field and min. 7 years’ related mechanical/operations experience and/or training (including military training)
• Extensive understanding in Pharmaceutical/Biotech cGMP and safety requirements
• Ability to read mechanical drawings, electrical schematics, and P&IDs.
• Team player willing to learn from others and train personnel.
• Basic knowledge of control system programming.
• Basic knowledge of CMMS systems and architecture.
• Must be willing to work in clean room environments.
• Strong troubleshooting ability of equipment and processes.

Preferred Qualifications

• Some electrical experience strongly preferred
• Start-up experience in Pharmaceutical/Biotech strongly preferred.
• Bausch and Strobel Filler & SKAN Isolator experience preferred.

Why Gene Therapy?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

Biogen is accelerating gene therapies that may one day help transform the way we treat neurological diseases. The facility includes the following areas: Office, Gene Therapy Production, Laboratory, Clean Utilities, Warehouse, and support areas including a cafeteria. This role will support the construction, start-up, and validation of the facility, equipment, and support areas.

All your information will be kept confidential according to EEO guidelines.