• You will be responsible for the commissioning, Qualification, and Validation Services • Lead in the planning, troubleshooting, and execution of the commissioning, qualification, and validation of a wide range of equipment and systems common to the pharmaceutical manufacturing industry • This includes systems, equipment, facilities/utilities, cleaning, laboratories and processes • You will lead and manage a wide range of project engineering activities including equipment research, coordination with third party OEM’s, compilation of technical reports, capital equipment cost analysis, and line design tasks • You will ensure that tasks, risks, people, resources and budgets are managed effectively • You will oversee and manage OEE improvement campaigns on existing packaging lines • You will lead and manage quality assurance and regulatory/GMP compliance projects • You will lead and manage project for remediating quality and compliance issues • Auditing Services: CFR 21 Part 11 assessments through mock FDA Inspections • Visual inspection: Specialized services including requirements development through OEE improvement as well as process development, SOP development and technical training for manual, semi-automatic and automated visual inspection • You will develop documents and execute IQ/OQ/PQ on client’s equipment • You will develop documents preventative maintenance, validation standards, and SOP’s • You will assist with a wide variety of internal projects, as needed and instructed by the Head of Department • You will assist with business development activities in collaboration with the Business Development Manager. Tasks include participation in trade shows, professional conferences, tech talks, webinars, etc. • You will assist in the mentoring and training of junior team members as requested by head of department