Lead Calibration & Maintenance Specialist

About Us

Pinnacle Transplant Technologies is a multi-service tissue bank committed to honoring the gift of donation and improving patient's quality of life through the processing and distribution of high-quality allograft implants. For over a decade, Pinnacle has helped surgeons improve the lives of thousands of patients. We offer a comprehensive portfolio of products and solutions across multiple market segments, including Spine, Sports Medicine, General Orthopedics, Trauma, Dental, and Regenerative Medicine. Pinnacle is registered with the Food and Drug Administration (FDA) and accredited by the American Association of Tissue Banks (AATB).

How You Contribute to Pinnacle Transplant's Success

The Lead Calibration & Maintenance Specialist will report to the Manager of Facilities & Equipment and is responsible for all cold storage equipment, manufacturing cleanroom environments, equipment, machines, fixtures, tools, jigs, and processes used to produce human bone and tissue allografts in accordance with company SOPs, AATB standards, and federal and state government rules and regulations.

Work hours: Monday-Friday, approximately 7:00 am to 3:30 pm (Hours may include evenings and weekends, as needed)

Work environment: Office Environment in a Manufacturing facility with some interaction within Manufacturing/Cleanroom

Location: North Phoenix, near 19th Avenue and Pinnacle Peak Road

Pay Rate: $90,000-108,000 dependent on experience

What You Will Do

• Supervise and perform the calibration, maintenance and repair of equipment or instruments used to measure and monitor properties or conditions of manufacturing products and environments and ensure they are qualified within defined parameters.
• Oversee and perform routine inspection and testing to ensure conformance to established calibration standards.
• Train associates on new equipment calibration and best calibration practices, and research and troubleshoot complex problems.
• Understand industry and quality concepts and standards such as ISO, GMP, etc.
• Learn and apply some Lean principles achieving improved processes as measured by better quality, lower cost, and reduced lead times.
• Improve equipment and infrastructure uptime by collecting and analyzing downtime data and taking corrective actions using Pareto principles.
• Ensure all staff and contractors comply with applicable OSHA, ISO 13485, FDA, cGMP, cGTP, HIPPA, AATB, and PTT Quality Management System (QMS) standards.
• Assist area Manager with Leading/Coaching/Developing/Directing work within the Facilities/Equipment department.
• Support and maintain 5S practices and standards.
• Exhibit teamwork, collaboration, and respectful interactions.
• Stay current on all company required training.
• Closely apply and follow up all SAP (system applications and products) to manage notifications, parts ordering, job history recording, and ensure work order/service report is closed after work completion with updated report and attachments.
• Develop and implement standard work procedures to continually improve overall team productivity.
• Schedule contractors for repairs/equipment calibrations.
• Draft and manage equipment files both on paper and via appropriate electronic systems.
• Collaborate with Regulatory Affairs, Quality Assurance/Control, and other department heads to promote continuous process improvement and effectively communicate through written and verbal partnership.
• Collaborate with Operations Leadership on projects, ad-hoc needs, planning work with minimal manufacturing impacts, and effectively communicate through written and verbal partnership.
• Take part in on-call rotation and is the owner of all things Calibration and Maintenance of Equipment.
• If assigned, may directly supervise Associates, which will include interviewing, hiring, coaching, developing, training, performance, and behavior, of the assigned Associates and/or department.
• Other duties as assigned.

What Qualifications You Will Bring

• 3+ years of experience managing facilities/equipment, calibration, equipment verification, qualification (IQ/OQ/PQ) in a federally regulated environment (FDA, DOD, DOE, FAA, etc.) preferred.
• Experience working in a controlled clean room or aseptic environment in regulated manufacturing preferred.
• Plant operations management, and materials management experience, preferably in a biomedical setting required. Similar experience in a commercial or industrial environment will be considered.
• Prior experience with Good Documentation Practices and controlled documents required.
• Proficient with desktop/laptop computer and general office equipment and software such as MS Office, Word, Excel, PowerPoint. Project and Visio preferred.

How You Will Grow

• Develop people leadership and development skills.
• Develop skills in equipment, engineering fundamentals, and FDA, OSHA, AATB, cGTP, state rules and regulations, and PTT SOPs.
• Continuous improvement activities within the department and processes.
• Lean Six Sigma and Lean Manufacturing practices.

Who You Will Partner With

• Daily verbal and written communication with Facilities Manager, Operations leaders, R&D staff, Finance, etc.
• Your Team. Regularly work in independent and team settings maintaining professional communication with all PTT team associates.

Where You Will Work

• You will work in an office environment in a manufacturing facility in North Phoenix, having periodic contact with human tissue and bone. You may be required to enter a cleanroom environment, where you will wear protective clothing including but not limited to hoods, face masks, gloves, boots, and coveralls. Hours may include evenings and weekends to perform tasks outlined in the job description.
• Use of processing or facilities equipment such as autoclaves, lyophilizers, centrifuges, heat sealers, shaker tables, ultra-low temperature freezers, reagent refrigerators, incubators, sonicators, calipers, gauge blocks, residual moisture analyzers, laminar flow hoods, ISO certified cleanrooms and clean areas, pH meters, and other related equipment.
• Position is very active and requires standing, walking, bending, kneeling, stooping, crouching, crawling, climbing and use of power tools and power equipment. May frequently lift or move items over 50 pounds.
• Position requires steel toe/composite toe boots to be worn at all times.

Benefits/Total Rewards

• Comprehensive medical, dental, and vision insurance, eligible first day of the month following your start date.
• Company-Paid Short and Long-term Disability Insurance.
• Company-Paid Identity Theft Protection.
• Company-Paid Life Insurance Policy of $50,000.
• 401(k) Profit Sharing Plan with a 4% company match, eligible first day of the month following 90 days of employment, and 100% Vested from the start of plan.
• Additional benefits such as: Voluntary Life/AD&D, Accident, Critical Illness, Hospital, and Pet Insurance.

Paid Time Off:

• (4) weeks paid vacation, prorated based on quarter hired.
• (1) week, 40 hours of paid sick time. Accrual starts at date of hire per pay period. Use available after 90-days of employment.
• (10) annual paid holidays.