John Henen

About John Henen

Driven and dedicated engineer with extensive experience in various validation and qualification roles. Proven ability to manage multiple projects simultaneously in a fast-paced and dynamic environment while meeting challenging deadlines. Detail oriented with superior communication, organizational and problem solving skills with excellent ability to plan and prioritize tasks. A team leader who able to bring energy, and enthusiasm to motivate team members to meet targets and achieve objectives in a timely manner. Key Achievements Design validation plans and develop/executed validation protocols such as URS, FAT, SAT, IQ, OQ, and PQ for various types of pharmaceutical liquid and solid dosage equipment such as mixers, fluid bed dryers, coating pans, tablet presses, liquid and solid dosage fillers, soft capsule fillers, bottle orienteers, cappers, checkweighers, and cartoners. Designed and executed automated process control systems validation test functions. Testing included input/output points (I/Os), interlock verification, HMI navigation, functional alarms, and HMI security levels access. Conduct temperature and humidity mapping studies for stability chambers, refrigerators, and freezers as well as manufacturing rooms and warehouse spaces using various types of data loggers.Professional Skills Excellent experience in Validation e-system (ValGenesis), Calibration and Maintenance Management e-systems (Blue Mountain and Oracle EAM), and Quality Management e-system (Agile). Expert in Microsoft Office Suite including Word, PowerPoint, Excel and Project. Excellent experience in validation project management. Extensive experience in implementing validation techniques for various manufacturing equipment. Strong organizational skills with ability to plan and prioritize tasks. Strong communication skills and demonstrated ability to communicate with a high level of technical understanding. Extensive knowledge and understanding of FDA regulations and pharmaceutical industry guidelines. Strong experience working in and maintaining cGMP environment.

Experience

1. Equipment Validation Engineer Iii

   Otsuka ICU Medical LLC

   May 2025 — Present · Austin, TX, US

   Design validation plans, develop validation protocols and lead/execute validation activities for new or modified manufacturing and packaging equipment. Ensure validation strategies are in alignment with validation policies, procedures and regulatory requirements. Coordinate implementing and scheduling of validation activities with affected departments- Evaluate validation test data to determine whether the system has met validation acceptance criteria or to identify root causes of non-conformances. Prepare detailed reports based on results of validation tests- Own investigations and author deviation reports in the event of non-conformances; support in identifying root cause, determining and completing corrective/preventative actions- Author Standard Operating Procedures (SOPs) associated with validation procedures and processes. Generate Change Controls and execute tasks associated with Change Controls- Review and approve engineering studies as pertains to the validation of existing and new manufacturing and packaging equipment, and assess the impact of proposed changes to cGMP related systems- Conduct periodic reviews to evaluate the equipment validated state during the review period and ensure the current equipment standard operating procedures are up to date. Identify gaps in validation protocols and equipment documentation to develop comprehensive plans for correction- Spearhead the validation colleagues and technicians training on the new equipment periodic review program and manage to assist them to decrease yearly carryover rate- Supervise validation technicians and validation consultants to provide project direction and technical guidance during validation projects. Conduct technical validation training to production personnel. Interview possible validation candidates and mentor new hires.

Education

• New Jersey Institute of Technology

  Master of Science (M.S.), Pharmaceutical Engineering

  2011 — 2013

• Capella University

  Master of Business Administration - MBA, Project Management

  2021 — 2023

• New Jersey Institute of Technology

  Bachelor of Science (B.S.), Biomedical Engineering

  2006 — 2011