SUMMARY OF POSITION
Under the direction of the Strategic Maintenance Supervisor, the Maintenance Sustainability Specialist is responsible as Engineering representative to support all activities related site projects, new product introduction and process improvement projects for commercial products directly linked to compliance and business continuity requirements. These activities include but not limited to having the oversight for the Engineering perspective change control system, compliance and implementation of each project under the engineering scope. Implementation of improvement manage the Quality deviation system and CAPA implementation. Serve as a backup for SAP transaction related to introducing new equipment and other transactions related to the Engineering module.
PRIMARY RESPONSIBILITIES
Responsible for the completion of the deviation (minor and major risk deviations), this includes the execution of the resolution report, and root cause analysis using the problem-solving tools.Responsible to manage the CAPAs (correction and preventive actions) system. This includes the completion of the CAPAs on time and the tracking of the system to ensure the closing on time. Develop CAPA effectiveness plan if required. Manage CAPAs / Deviations extension (if it's required).Provide training as part of the onboarding process.Lead and manage process improvement related to cost saving, such as energy, capital, sustainability, efficiency, and cost avoidance.Manage the Change Control module through the initiation and execution of IQ / OQ / PQ and risk assessments.Responsible for Department Quality metrics, this includes the preparation and participation in the site Quality Council meeting and presentations. Monitor and track trends and develop action plans to avoid recurrences.Responsible and liaison person with Quality / Safety / Environmental team during internal, external, and regulatory audits. This includes active participation during the auditing process, getting all the documentation associated and interactions with the auditors (if needed).Perform Gemba Walks, Go and See, participation during the Tier Process, and process-specific updating to identify opportunities and perform the necessary actions.Evaluate the Corrective, Preventive, and Predictive maintenance tasks to identify opportunities and complete the actions needed to reduce the spare parts consumption, downtime reduction, and all cost avoidance related to the maintenance activities using the DMAIC methodology, 5 Whys, Fishbone, and other techniques.Support as a backup of the Maintenance Compliance Technician to ensure that all Standard Operating Procedures (SOPs) / forms and guidelines are within their effective dates and assist in the document revision workflow.Manage department documentation by generating reports quarterly and on an annual basis, including the documentation required for the Annual product review.Backup for the master data updating for the engineering department, as applicable to the equipment and instrument maintenance plan (ARPM), and changes related to improving work order tasks.Support as a backup for the maintenance compliance technician for SOP, forms, guidelines revision within their effective dates, and assist in the document revision workflow.Comply with all environmental training procedures, current Good Manufacturing Practices (cGMP), permit conditions, and internal notifications of any environmental event.Perform any other related job-related duties as required or that may arise in the future.REQUIREMENTS
Education/Experience
- Bachelor's degree in engineering (Mechanical, Electrical, Chemical, Industrial), Science base.
- Minimum of one (1) to three (3) years of experience in highly regulated industry like Pharmaceuticals and/or Medical devices.
Licenses and/or Certifications
- Lean / Six Sigma Certification; Yellow, Green, or Black belt, preferred
Technical Competencies
Program management, and organizational skillsManage Problem Solving, understanding of regulations including OSHA, EPA, DRNA, and GMPs.Knowledge of Operational Excellence methodology and tools, preferred.Knowledge to read and understand drawing and schematic diagramAnalytical problem solving.Ability to work with people, contractors, and technical writing.Knowledge of computer programs such as MS Word, MS Excel, MS PowerPoint, building automation applications, Minitab.PHYSICAL DEMANDS
- Willing to work rotating shifts.
- Position will require being stand for long periods of time, climbing stairs, and be seated.
- On occasions, physical effort is required to move raw materials.
- Willing to travel both locally and domestic.