Russ Henrikson Email & Phone Number

Easton, Pa, Us

Allentown, Pa

Bethlehem, Pa

Easton, Pa

• Support Quality Organization• Support New Product Development• Assist in Warranty Return reductions.

Swiftwater, Pa

• Computer Validation processes and activities supporting the Information, Technology, and Solutions (ITS) Departments. • Provide validation support for GMP projects in ITS as the Validation Expert (VEX).• Support VEX role in the deployment of global change control system. • Development and /or review of validation deliverables and activities such as: Criticality Assessment, Validation Plan, User Requirements, Risk Analysis Report, Specifications, Test Plans, Test Script(s), Anomaly Report(s), Test Reports, Authorization for Use, Validation Reports, and Change Management records.• Support usage of the IS Project Methodology, assist with defining validation strategy for GMP projects based on computer validation procedures, assist with training on IS compliance topics (e.g. validation), and develop and/or review IS procedures.• Enforcing 21CFR11 and ISO9001 standards.

• Responsible for project leadership of long term, integrated quality systems and solutions; including developing program / project timelines and successful implementation. Manages the quality aspects of projects so that key divisional quality goals are met.• Responsible for assuring that the site is operating in compliance with regulatory requirements when conducting: • Process validations • Equipment qualifications • Serialization and electronic pedigree systems • Transfer of new products from R&D into Manufacturing.• Responsible for managing several QA/compliance projects simultaneously and ensuring that all operational & compliance aspects meet planned dates.• Aligns project objectives and milestones with Corporate, regulatory and industry initiatives.• Leads and facilitates project team meetings to oversee completeness, timeliness, accuracy and effectiveness of activities.• Conducts benchmarking activities.• Remains current in regulatory expectations and industry practices.

Allentown, Pa

• Experience with drug packaging validation and documentation required to complete a validation package: URS, FRS, DS, IOQ, PQ & PV.• Experience in quality assurance remediation and validation plans for a drug manufacturer.• Strong SOP writing and validation protocols centered on packaging validation for pharmaceuticals.• Ability to document and execute protocols on various robotic and packaging systems.

Project Manager/Senior Staff Engineer• Overall responsibility for the strategic planning, budgeting, and coordination of individual projects in support of our Engineering Projects. • Successes include implementation of major projects such as; SAP-QM, SAP-PM, Equipment Performance Monitoring (Wonderware).• Responsible for the project management activities for implementation.• Provide improvements for OEE, machine operations and determining which efficiencies can be utilized through out the manufacturing processes.• Track and ensure all issues are addressed prior to implementation and production. • Ensure that project focus is maintained• Provide leadership to the project• Empower resources to make decisions• Assist with issue resolution through effective decision making / facilitation• Conducts project status conference calls, performs tracking of project progress against baseline schedules, coordinates project team members’ efforts in producing project deliverables and meeting project deadlines.• Prepares periodic schedule updates and progress reports to project team members, management and stakeholders.

Validation/Quality Engineer• SAP-QM Site Lead for PA; involved in implementation of SAP-QM at our manufacturing facility. • Responsible for coordination of various site activities, provide status reports and strategy, project plan, training in details of QM master data and author, review and approve various test cases.• Performs final review of test data/reports to ensure conformance to the established specifications and other related operating procedures. • Investigates deviations to determine the impact on the product quality, the cause and corrective actions to preclude further deviations of a similar nature. • Determine quality improvement by analyzing quality failures. • Perform root cause analysis and implementation of corrective actions. • Investigate work procedures and work orders. • Responsible for continual improvement activities to enhance the quality system, such as 6 Sigma studies. • Update policies and procedures to improvement production efficiency. • Develop training program to build quality awareness. • Provide assistance to the materials management function. • Provide technical support as required/appropriate to the production operation. Prepare, execute, and finalizes protocols (USR, IQ, OQ, PQ…etc) for validating new and improved pharmaceutical manufacturing processes, equipment, and products. • Prepare and present technical investigative reports to management as directed.• Backup support for IT personnel. • Able to make independent decisions without supervisory assistance.• Familarity with reading drawings and use of measurement instruments, including hand gauges and CMM, GMP and FDA requirements.

Project Management Professional Certification

Bs, Aerospace/Mechanical Engineering

Activities and Societies: Kappa Delta Rho, American Institute of Aeronautics & Astronautics, Society of Woman Engineers (I'll explain that.