Process Expert II/Engineer - (Broomfield) in Boulder, Colorado For Sale
Job Description**No relocation available. Local candidates only.** PURPOSE Provide front line expertise and mentorship for all process-specific and equipment issues to ensure safe and compliant execution of processes and equipment, implement continuous improvement in safety, quality, and efficiency projects, and perform all activities in alignment with HS&E , cGMPs, SOP's, and applicable regulatory guidelines. MAJOR ACCOUNTABILITIES cGMP Compliance *Lead and support cross functional team(s) to identify event, scope, root cause, appropriate corrective actions and product impact assessments *Author investigation reports, *Identify department trends in regards to deviation, continuous improvement, etc. *Provide and implement solutions for identified gaps *Maintain work in an inspection ready state *Prepare and lead presentations as requested *Provide support during inspection activities Investigations *Author investigations and work with cross functional teams to determine scope, product impact, root cause and corrective actions for deviations from manufacturing procedures by interviewing, sampling, and applying the use of quality tools and techniques. *Illustrate strong communication, project management, and leadership skills including the ability to interact and influence others at various levels of the organization. Collect, compile, and analyze relevant data during the investigative process to ensure objective support for investigation outcomes. *Determine appropriate corrective actions and preventative actions (CAPAs) to prevent reoccurrence of the deviation with realistic timelines for completion. *Foster collaborative relationships focused on high quality investigations, meaningful corrective actions and the reduction of deviation generation rate. *Work with minimal supervision to drive deviations to closure. *Possesses the ability to articulate complex thoughts and issues into writing in such a manner that an educated, but uninformed reader can understand and make decisions based on the written investigation report. Single Point of Contact (SPoC) *Provide front line support to manufacturing, working with cross functional and shift teams, focusing on manufacturing each batch safely, on time, in compliance with the batch instructions, applicable procedures and quality requirements *Lead cross functional team(s) when issues arise to identify of root cause, scope, corrective actions, product impact assessments and plan to return equipment and systems to operations *Conduct data gathering and experimentation in order to identify root cause and/or characterize equipment/process performance *Provide rotating on call floor support *Identify and drive improvements to troubleshooting methodologies, investigation process, and other business/cGMP processes *Develop subject matter expertise for specific processes and technology *Author SOPs and other technical documents *Seek knowledge and develop troubleshooting skills *Organizes and manages team meetings, information, and communications *Responsible for regular status communications to team and management *Support maintenance-related items (PMs, FMEAs, spare parts, etc.) Equipment Validation Support *Lead, author, or support in the development of user requirements and selection of pharmaceutical equipment *Support development of procedures and safety documentation of equipment *Support facility, equipment, and process fit assessments for new products *Provide all necessary information to perform the equipment qualification lifecycle activities *Provide support on equipment performance qualification studies Change Control *Participate and/or lead (case by case) the change controls associated with equipment and related processes. *Provides training to Operators associated with changes, as needed
Source: http://www.juju.com/jad/xxxxxxxxwhd11a?partnerid=af0exxxx314cbc501beebacaxxxx739d&exported=True&channel=staticfile&hosted_timestamp=xxxxa345f27ac5dc3bf488bfa8c716c7db9ec52ecb226axxxxxxxxxxxxxxxx5b