Job Title Process Engineer Requisition JR000012605 Process Engineer (Open) Location Hobart, NY (Pharma) - USA036 Additional Locations Job Description Summary Improves safety, quality, and productivity of a fast-paced solid dose pharmaceutical operation. Consistently seeks for and evaluates methods to improve overall customer satisfaction through improved manufacturing efficiencies. Serve as main point of contact for manufacturing and/or packaging processes in their area in regards to safety, quality, and continuous improvement activities. Essential Functions Department rep for FAT and SAT Documentation Completed (Engineering owns) Coordinates the documentation of FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing). Accurate, Up-to-Date SOP’s Leads the SOP review process by actively managing procedural updates and driving cross-functional collaboration to meet due dates. Manages tracking system to ensure effective communication on status of SOP updates. Prepares reports for management on compliance. Operations Documentation Ensures rework costs are correctly identified and obtains approvals from client on how rework will be performed. Ensures rework is correctly completed. Provide technical support and problem resolution. New Product Launch Facilitated in Department Assist in the successful and on time completion of documentation and implementation of new process and product transfers in assigned department. Production Processes Managed Ensures the official documents receive appropriate sign-offs. Identifies and implements improvements to existing processes using continuous improvement tools. Ensures that processes comply with all cGMP regulations in regards to process and cleaning validation. Completes exception investigations and implements effective corrective and preventative actions to prevent recurrence. Regular participation in production daily operations meeting and team problem solving efforts. Work with plant safety to maintain process specific safety information. Assist in developing training programs and/or SOPs to enhance skills sets and reduce defects. Support Customer or Regulatory agency audits as the subject matter expert for assigned processes. Work with Focus Factory Manager, Engineering Services Lead and Project Engineering to develop project scope and cost details for capital budget preparation. Candidate may also have to assist in production efforts when necessary Minimum Requirements Education BS degree in Industrial, Manufacturing, Chemical Engineering or Packaging Engineering/Technology or related field preferred. Solid knowledge of chemistry, physics and engineering principles. Experience: Minimum of 1-3 years of experience of related experience solid dose production experience. Experience with manufacturing or packaging processes. Preferred Skills/Qualifications: Ability to effectively communicate with all levels of the organization, from operations to senior management, both oral and written format Knowledge of FDA and DEA regulations Knowledge of Quality Systems Knowledge of cGMPs for Finished Dosage Products Understanding of basic statistical principles, basic knowledge of validation principles, techniques, and regulatory experience Ability to quickly identify, communicate and/or resolve issues Other Skills/Competencies: Strong working knowledge of Microsoft Office products including Word and Excel Organizational Relationship/Scope: Drive for Results Sets and maintains high performance standards for self and others that support the organization’s strategic plan and holds self and other team members accountable for achieving results; ensures organizational systems, processes and people are aligned to support strategic objectives; regularly evaluates self and team on goal attainment, processes used to achieve goals, and competitive benchmarks. Problem Solving Uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis; looks beyond the obvious and doesn’t stop at the first answers. Timely Decision Making Makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure; able to make a quick decision. Written Communications Is able to write clearly and succinctly in a variety of communication settings and styles; can get messages across that have the desired effect. Process Management Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can’t; can simplify complex processes; gets more out of fewer resources. Time Management Uses his/her time effectively and efficiently; values time; concentrates his/her efforts on the more important priorities; gets more done in less time than others; can attend to a broader range of activities. Incorporates Mallinckrodt Core Values in daily routine: Patient-Centric: Our decisions and actions are guided by our commitment to improve lives. Collaborative: We are inclusive and work together towards our common goals. Innovative: We are agile, always seeking new ways to continuously improve our performance. Integrity: We do what we say we are going to do. Working Conditions: Works an equal amount of time on the production floor in a manufacturing facility and an office type environment. The time spent on the production floor may be extended periods of time within a manufacturing facility.