John Cunningham Email & Phone Number

Mesa, Az, Us

Phoenix, Arizona, United States

Scottsdale, Arizona, United States

Manage Capital equipment projects ranging from 15k - 450k, from budgeting, planning through installation and qualification.Oversee process improvements including implementing principles of single piece flow, line relay outs, and in-coming component inspection resulting in higher yields downstream.Collaborate with R&D in development of risk assessments, test methods, engineering studies, clinical trials, design validation / verification, and process validation.Direct and coordinate engineering activities supporting manufacturing yield, quality, NCR and CAPA evaluations / investigations, productivity, cost reduction and regulatory compliance.Work with suppliers to commission custom equipment to ensure timelines, specification compliance and documentation meet quality and company policies.

California, United States

Managed ownership of nine equipment types, delivering 24/7 support to ensure seamless manufacturing production.Lead C&Q activities for the implementation of 4 updated systems in alignment with Amgen’s Commissioning and Qualification Process (CQP) to increase testing capacity of systems by 50%.Ensured that new cGMP equipment was installed and maintained in a validated state through IQ, OQ, PQ procedures.Supported projects in defining strategies for quality systems verification and worked with the process development/validation team to develop and document appropriate practices for characterization. Performed and oversaw monthly and weekly preventative and general maintenance on validated systems. Monitored, evaluated, and investigated 8 deviations related to Analytical equipment complying with Quality Management System requirements.

•Oversee the hiring, training, mentoring, assessing, and scheduling of Aquatic staff•Ensure Aquatic staff provides effective parent and child feedback, addresses concerns and provides solutions•Maintain the pool, pump room, and pool environment to ensure adherence to the Aqua-Tots brand standard in safety, cleanliness, and overall appearance