Job Details

Description

We are a leading global spine and orthopedics company with a premier portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system. Our combined company is over 1,600 strong, with products distributed in 68 countries worldwide and a global R&D, commercial and manufacturing footprint, and this is just the beginning!

Come join our global team of dedicated professionals who through their extraordinary efforts demonstrate every day their commitment to our mission of improving the lives of patients. At SeaSpine and Orthofix our culture is built around Integrity and the core beliefs we live by: Exceed Expectations, Work Together, Be Respectful, Get Lean and Have Fun!

How you will make a difference:

Site leader for mechanical system repair, maintenance and installation.  Accountable for the performance and uptime of mechanical systems throughout the Irvine facility.  Provides support to manufacturing concerning operational systems, equipment procedures, and standards and practices in various building tasks. Possesses knowledge of and trains junior team members on mechanical, HVAC, refrigeration, lyophilization, autoclave sterilization equipment, fire systems, stand-by emergency power, extraordinary and preventative maintenance. 

Your key responsibilities:

• Provides leadership and support for lyophilization, refrigeration and autoclave equipment
• Manage the design, acquisition, installation, and commission of lyophilization, refrigeration and autoclave equipment and parts to support manufacturing
• Provides and manage technical and mechanical support for maintaining, repairing, troubleshooting, and modifying lyophilization, refrigeration and autoclave sterilization equipment
• Create and/or modifies equipment maintenance procedures
• Manage outside vendors with design, build, installation, qualification, and sustaining support of lyophilization, refrigeration, autoclave sterilization equipment and processes
• Performs equipment performance testing
• Performs all aspects of lyophilization preparation such as cleaning and leak tests.
• Performs investigation for non-conformance equipment events
• Performs QS validation input and support for new equipment validations
• Reviews and approves calibration datasheets, work orders and change controls
• Collaborates with Manufacturing, Engineering and Maintenance functions to provide training for production-related equipment.
• Assist in performing equipment preventive maintenance (PM) as scheduled in compliance with the Quality System. Ensure PM files are completed in timely manner and documented appropriately
• Assist in performing unscheduled service /repairs, extraordinary maintenance and responding to equipment and facility integrity issues and send updates on the status of equipment
• Perform daily inspection of the facility (inside and outside) and perform general facility maintenance
• Ability to define problems collects data, establish facts and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and make informed decisions.
• Participate with department leadership in the hiring of workers, organize schedules, and assign work activity.
• Perform training to ensure individuals have all the requisite skills. Additional responsibilities include developing and implementing maintenance procedures and evaluating technician/journeyman/apprentice work to ensure quality operations. They also investigate accidents and prepare relevant reports.
• Coordinate with outside contractors and supervise contractor’s technicians in performing annual and bi-annual maintenance or services for applicable equipment (i.e., AC units, Air Handler, Condensers, Cooling tower, Lyophilizers, back-up generator, RO/DI sanitation) also within compliance of our site QS and EH&S policies.
• Participate in the development of department goals and objectives as well as policies and procedures; make recommendations for changes and improvements to existing standards, policies, and procedures; participate in the implementation of approved policies and procedures; monitor work activities to ensure compliance with established policies and procedures.
• Perform miscellaneous repairs as required (installing white boards, changing light bulbs, hanging pictures, etc.)
• Ability to work overtime and holidays as required.
• Ability to respond to after hour emergencies to support operational requirements.
• Must be able to operate a company vehicle and travel between work sites in accordance with the SeaSpine Company Vehicle/Driver Policy.
• Must be able to adhere to SeaSpine’s Health and Safety and Quality guidelines as they relate to working within controlled environments
• Actively lead and support process improvement and cost saving initiatives
• Must be able to work at both Irvine and Carlsbad locations when needed
• Perform other job duties as assigned

Who you are:

• BS/BA or equivalent work knowledge and experience
• 10+ years industry experience with lyophilization and refrigeration equipment in a cGmp environment
• Experience in medical device manufacturing or similar industry
• Experience with automated and semi-automated equipment and processes
• Knowledge of diagnostic manufacturing lyophilization equipment design, operation, repair, and maintenance
• Knowledge and experience of equipment and process validation
• Knowledge of PLC’s, refrigeration, vacuum chambers, and chillers
• Experience with developing floor plans, site drawings, engineering drawings, pulling building permits
• Practical experience in project management using associated tools such gnatt charts, project timelines
• Experienced in developing budgets related to department, build out projects, and equipment
• Possesses excellent leadership skills
• Good communication and organizational skills mandatory
• Knowledge of safety codes and practices
• Ability to balance and prioritize multiple projects
• Ability to assume new or responsibilities with minimal supervision
• Ability to multi-task in a fast-paced environment
• Ability to work independently with minimal supervision
• Possesses knowledge of mechanical equipment, HVAC, refrigeration, fire systems, stand-by emergency power, and preventive maintenance
• Refrigeration and or control systems experience a plus
• Electrical and mechanical background a plus

The anticipated base hourly rate for an employee who is located in California this position is $40.00 to $50.00 per hour, plus bonus, and benefits. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type and years of experience within the industry, education, etc. The Company is a multi-state employer, and this pay scale may not reflect the pay scale for an employee who works in other states or locations.

We are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, caste, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), domestic violence victim status, political affiliation, or any other protected status in accordance with all applicable federal, state, and local laws.

 This policy extends to all aspects of our employment practices including, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.