Senior Mechanic, Maintenance - DPF

Role Summary

You're excited about the opportunity to join the Maintenance team at a brand new facility. No job is too big or too small as you'll be counted on to wear many hats in support of our xenotransplantation efforts. The Senior Mechanic, Maintenance is primarily responsible for timely completion of preventive maintenance, intermediate level troubleshooting, and highly effective repairs of GMP manufacturing equipment, clean utilities, and all associated support systems. This role will also support monitoring & maintaining all base utilities, buildings, electrical systems, water systems (incoming, pure, & waste), steam systems, HVAC & refrigeration, Life Safety Systems, and grounds as necessary in a cGMP Facility.

Responsibilities

• Complete assigned preventive & corrective maintenance and provide proper documentation of work performed in the computerized maintenance management software (CMMS) in accordance with policies and instructions
• Ensure production and facility systems operate efficiently and properly by following set processes in addition to monitoring and inspecting equipment and facilities
• Perform highly effective repairs of manufacturing equipment and all associated support systems and utilities with limited or no oversight required
• Assist or perform monitoring and maintaining boiler system including chemical testing and charging of brine tanks for feed water softeners as assigned
• Request assistance from more experienced or senior team members as needed to complete work in a safe and effective manner and aid less experienced or junior team members as requested or tasked
• Adhere to applicable standard operating procedures (SOPs). Attend and fully participate in all assigned training
• Ensure all facility and production systems are cGMP compliant
• Ensure that vendors and contractors are trained in applicable company procedures regarding safety, environmental, and health in order to provide effective service in compliance with all ordinances such as electrical and construction codes
• Assist in special projects and/or construction projects, which may include demolition, renovation, and new construction
• Participate in emergency and after hours on-call rotation in order to ensure continuous operations of facility and production systems
• Perform other duties as assigned

Qualifications

• Required: H.S. Diploma or General Education Degree (GED)
• Required: 6+ years of experience as maintenance personnel in an industrial, pharma/bio, or manufacturing environment
• Required: Proficient cGMP and ISO regulatory knowledge
• Required: Ability to successfully interact with various levels of employee and management
• Required: Ability to convey complex technical information in an easily understood manner
• Required: Ability to interpret and achieve internal and external clients or customers‚Äô needs and expectations during product or service development, manufacturing, marketing, delivery, and/or support
• Required: Ability to troubleshoot complex machines/ MEP/cGMP systems and components to ensure the safe and proper operation and adherence to building and local codes
• Required: Ability to work independently on projects or assignments without close supervision or detailed instructions to maximize workplace productivity
• Required: Ability to maintain records and reports (e.g., time sheets, daily work orders, time reports) to provide information and documentation and to comply with departmental policies
• Required: Ability to work in an environment that includes dust and other debris using Personal Protective Equipment (PPE) in the installation, maintenance, alteration, and repair of building/facility systems
• Required: Ability to adhere to all regulatory and compliance requirements defined in Good Manufacturing Practices (cGMPs)
• Required: Willingness to learn new concepts to fully understand aseptic technique and demonstrate proper cleanroom behavior
• Required: Ability to follow and execute Standard Operating Procedures (SOPs)
• Required: Basic computer skills needed
• Required: Intermediate knowledge of Building Automation Systems
• Required: High level understanding of equipment and methods of operation, including but not limited to: manufacturing/process equipment, BMS/BAS, fire/life safety, purified water, environmental monitoring, and other systems
• Required: Must not have interaction with pigs outside the company

Additional Requirements

• Travel: up to 5% long term; may require additional travel during the first year