Arnold Miga

Validation Manager / Validation SME
17 years of GMP experience within global pharmaceutical and biopharmaceutical corporations, market leading products, benchmark GMP & quality systems and world class facilities with great safety record. 
15 years of CAPEX experience in large biotech start-ups or major biotech facility upgrade projects.
Thorough understanding of Biopharmaceutical USP, DSP and Media/Buffer Unit Operations, from scientific, technical, operational, QA and CVQ (Commissioning, Qualification and Validation) perspectives. 
Career highlight: Head of QA Validation in a new Biotech startup reporting to Site QA Director, supporting 15 CVQ/validation workstreams and 8-11 SMEs with technical and QA Validation expertise. This role involved advanced risk assessments, troubleshooting and decision making related to all production equipment, Utilities, CIP, SIP, HVAC, cleanroom qualification, thermal mapping Buffer/Media process validation, cleaning validation and transport validation. 
Proven experience in CVQ workstreams, from URS, through IQ/OQ/PQ/PPQ, into periodical monitoring.
Extensive campaign/project management, scheduling, budgeting and manloading the activities.
Proven ability to lead and manage personnel (employees and contractors).
Extensive CDMO experience incl. regular meetings with customers and sending unit counterparts. 
Site Audit experience as part of QA Leadership (walkdowns), defended internal audits and submission to FDA.
Cleaning Validation SME, delivering multiple end to end validation campaigns in biotech startups and existing multi-product facilities to most current industry and regulatory standards, from concept to summary reports, including generation of key strategic documents, science & risk based approaches, protocols, SOPs, continuous improvement, supporting IQ/OQ/PQ of CIP systems and parts washers, CIP cycle development & optimization.
Proven track record of major ($500k+) cost saving initiatives related to validation, with strong foundation in process improvements and Lean Six Sigma methodology (Degree in Manufacturing Operations Management and certified Yellow Belt with many far more advanced projects since).