Senior Process Engineer

Looking for a Senior Process Engineer to act as an SME for critical process operations within formulation and filling operations. Strong process/mechanical/controls knowledge of key process equipment to include commodity washers, depyrogenation tunnels, autoclaves, fillers, cappers, vision systems, CIP/SIP processes and formulation systems such as mixing tanks. Must have project management skills, knowledge and application experience of technical design reviews, commissioning and validation for pharmaceutical processes. Must have a solid understanding and knowledge of pharma regulations and cGMP principals and demonstrated ability to apply knowledge to process improvements and changes. Responsible for interfacing with auditors and presenting on site processes. Responsible for leading and supporting root cause analysis and developing engineering resolutions for corrective actions. Troubleshoot production related equipment/process issues. Organize, oversee and analyze testing associated with the development of new process technologies and the support of new product introductions and tech transfers. Work closely with Corporate R&D and technical services to develop and confirm critical and key process parameters equipment and processes to ensure acceptable quality. Plan, review and approve engineering studies for engineering cycle development and research. Lead factory acceptance testing and ensure protocol execution is per plan. Support installation, operational, and performance qualification activities. Direct the work of other process engineers and contract engineering resources, to include performance evaluations for direct reports. Establish methods for ongoing monitoring/trending of process/mechanical issues. Responsible for review and approval of site documents to include calibration reports, batch records, SOP`s, change control, and design specs.Skills needed- Mechanical Design, Electro Mechanical and Automation Controls, Pharmaceutical Industry and GMP Experience (preferred), Global Regulations for Drugs (Preferred)