The Opportunity

We're seeking a highly skilled Maintenance Specialist with direct Pharmaceutical compounding and filling Equipment experience who will be accountable for leading troubleshooting and issue resolution for highly complex mechanical challenges, providing coaching / mentorship / training of other Facilities personnel, and serve as owners or functional representatives on projects.   In addition, they are accountable to support the maintenance of process and utility equipment supporting production in Holly Springs.

Pre-Startup:

During the plant start-up project you will be on the User Team and be responsible for establishing the site’s maintenance program for compounding and filling equipment including procedures and training.  You will also be responsible for supporting FATs for compounding and filling Equipment.  While this role is focused on compounding and filling, you are expected to be able to flex to support other Holly Springs assets as well.  To accomplish this, you will partner and collaborate with our partner organizations (Engineering and MSAT, Quality, Supply Chain, Technical Development, Regulatory, CMO, Strategy).

Initially, you will perform a mix of remote and onsite work (first at the General Planner’s office, later at construction site/plant). You will transition to local full time on-site work once the site buildings are built and equipment delivered. Travel of up to 30% of the time is expected during the project phase.

Post-Startup:

• You will provide in the field execution of maintenance activities on GMP assets.  This will include both planned preventative maintenance and repairs / troubleshooting.  Supporting troubleshooting of PLC/automation is expected. This will be done while adhering to applicable SOPs, complying with cGMP, and adhering to Federal, State, Local, and Genentech safety standards.

• You will perform timely detailed documentation following Good Documentation Practices in electronic (e.g. SAP) and paper based systems.   

• You will create and facilitate continuing education for the maintenance staff to increase technical skills through formal and informal training, coaching and mentorship.

• You will provide assistance with identification of spare parts and BOM improvements to improve service delivery and reduce equipment downtime. 

• You will support Quality Record management through gathering information and providing SME input.  Proficient in Quality Management System(s).

• You will provide inputs to master data needed to support the maintenance program in SAP S4/HANA.

• You will need to understand controlled, classified environments, aseptic processing principles, and maintain associated qualifications for access.

• You will read and understand P&lDs, work from Standard Operating Procedures (SOPs) and leverage basic computer skills using word processors, spreadsheets, databases, and email.

Who You Are

• You have a High School diploma or equivalent with 7+ years of related work experience in an industrial / manufacturing setting with demonstrated strong mechanical aptitude.  An A.A., A.S., A.A.S., or Trade School Certificate is preferred with 5+ years of related work experience.  Specifically, experience with maintaining high performance pharmaceutical compounding and filling lines.

• You have an ability to organize and solve complex, unique or unprecedented problems through the regular use of ingenuity and innovation; consistently demonstrating courage and drive to ensure optimal business results.

• You are proficient in using AI and other digital tools to solve complex challenges

• You have familiarity with cGMP's, Health Authority regulations, and Quality Systems.

• Strong interpersonal, communication (written and verbal), project management, and time management skills

Work Environment/Safety Considerations:

• Candidates must be flexible to work overtime and adjust working schedule beyond normal work week. Work schedule may be subject to change based on the phase of the project and/or commercial demand. 

• This role will have a defined work shift but will require flexible working hours including overtime or on-call (sometimes in an emergency situations) to meet business needs.

• May work in the clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves, and steel toe boots.  

• Potential to work near hazardous materials, chemicals, and equipment as per company safety procedures and guidelines.

• Active role which includes lifting up to 35 lbs, navigating stairs/ladders/scaffolding, transporting equipment to the location of instruments, and working away from a desk for the majority of working shift.

• Be able to work extensive hours while standing

The expected salary range for this position based on the primary location for this position of Holly Springs, North Carolina  $81,400 - $151,200. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

Link to