Eric J. Johnson Email & Phone Number

Minneapolis, Minnesota, United States

Greater Minneapolis-St. Paul Area

Greater Minneapolis-St. Paul Area

Supervision

Greater Minneapolis-St. Paul Area

Medical Device Packaging, Equipment Validation, Investigate and Resolve Variances

Greater Minneapolis-St. Paul Area

Prepared and executed validation protocols and reports within a non-commercial biopharmaceutical facility for GMP equipment, computer systems, and critical utilities.Individually prioritized routine workload of 20+ simultaneous projects while harmonizing cross-functional teams to ensure internal buy-in and regulatory compliance.Provided quality review of technical specification documents for operations equipment.Performed quality tasks related to operations within laminar flow clean rooms (ISO 14644).Developed compressed air sampling procedure to ensure compliance with clean room requirements.Harmonized industry guidance along with four departments to verify compressed air quality.Maintained understanding of system critical components such as fans, motors, pumps, and other associated mechanical systems correlating operations and quality compliance.Focused team player ready to use broad experience to flow to the work as needed.Maintained validation status of computerized systems under pressure of constant change.Planned and coordinated critical utility quality testing with system owners, users, and support staff.Protocol template design and improvement to increase document creation efficiency.Implemented autoclave PQ with KAYE datalogger and BIs to support aseptic processing.Improved autoclave validation master plan to enhance regulatory and industry compliance.Executed coverage study of washer unit with riboflavin, UV light, and process equipment.Designed and implemented four season mapping of warehouse to meet ICH standards.Created change control and validation assessments to define project impact and scope.Scheduled protocol execution to meet process deadlines and eliminate production impact.Identified, facilitated, and implemented quality system tasks to close system integrity gaps.Generated and closed investigations to resolve deviations encountered during validation.

Front line team player within fledgling Validation Department that implemented validation activities within a highly competitive and multi-disciplinary pharmaceutical GMP facility.Supported creation and development of new Validation Department, replacing contractors.Authored protocol templates to reduce development time and increase productivity.Maintained site cleaning validation program through bracketing approach and assessments.Obtained BS in Business Administration to develop focus on business goals and processes.Reduced temperature qualification time using lean methodologies and premium supplies.Wrote and executed cleaning validation protocols and reports for multiple lines of product.Created, planned, executed, and reported equipment and computerized system validations.Supported outside engineering contractor to complete potent compound suite validation.Coordinated large qualification projects involving whole packaging lines, meeting deadlines.

Lincoln, Nebraska Area

Provided electromechanical system diagnosis, repair, and maintenance services to third shift manufacturing and packaging activities to reduce downtime and improve system reliability.Reduced equipment breakdown time through focused troubleshooting.Programmed PLC code to optimize equipment operation.Maintained specialized solid, liquid, and cream production and packaging equipment.Implemented change control action items for improvement of production equipment.

B.S.

A.A.S