Description
RESPONSIBILITIES:* Develops process validation strategy and writes and executes engineering studies and process validation protocols.* Supports the needs of manufacturing areas in terms of meeting the requirements for quality standards and compliant documentation, capacity, product availability and cost. * Coordinate and Support new equipment acquisition efforts including user requirement specifications, machine selection, installation, validation, employee training, and other related equipment responsibilities as required. * Assists in the development of manufacturing and inspection procedures. * Support the Manufacturing Organization in creation, review and release of MPI & Risk Management Activities * Responsible to originate/oversee/assist in the creation & release of change orders (COs) through Agile PLM software. * Acts as Subject Matter Expertise in GMP and Process & Machine Capabilities * Acts as a liaison to vendors with regard to contracted products, tools & fixtures, and their manufacture. * Know and follow all laws and policies that apply to one's job.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.