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Technical/Functional Skills:Equipment Engineering, Commissioning & Qualification, cGMP (Current Good Manufacturing Practice) documentation proficiency, SAP, SolidWorks, ACAD.Job Title:Installation, Commissioning & Qualification Equipment EngineerExperience Required:A minimum of 6 years of industry experience is required with at least 4 years of Equipment Installation, Commissioning & Qualification experience. Specific experience within the Consumer, OTC, or Pharmaceutical industry is must. GMP experience is must. Experience in a highly regulated environment is preferred. Demonstrated technical knowledge related to Equipment commissioning, de-commissioning, instrument calibrations, change overs and part designs. Experience with Solid dose, liquid dose and blister equipments is must.Roles & Responsibilities: Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies’ policies, procedures and guidelines, this position is required to:- Plan and execute equipment engineering assignments concerned with large life cycle management initiatives.
- Engage in the commissioning and qualification of the equipments and line clearances and decommissioning activities.
- Work closely with validation team and technicians for equipment decommissioning.
- Ensure instrument calibration are documented and up to date.
- Determine the appropriate Commissioning/ decommissioning activities for the equipment/system being commissioned / decommissioned.
- Write technical protocols and reports for equipment qualifications, line clearance, equipment removals.
- Lead and Co-ordinate activities with cross functional teams.
- Red line equipment layout and ensure drawings updates are made for line clearance. (mechanical, electrical, utility drawings etc.)
- Ensure equipments are updated in system or removed from the system.
- Plus to have the experience in Lock out and Tag out procedures
- Experience with mechanical design tools like AutoCAD and 3D design software (Inventor, Solidworks etc.). Sound knowledge of engineering principles and best practices.
- Conversant with international standards, ANSI, ASME and machine safety related guidelines.
- MS Office expertise, Technical Documentation.
- Good written & verbal communication, presentation skills.
- cGMP (Current Good Manufacturing Practice) working experience. cGMP documentation proficiency.
Physical Demands: Requires up to 25% travel based on business needs. Knowledge, Skills and Abilities: Ability to work in a cross functional environment relating to R&D, Marketing, Operations, Sales, etc is required. Previous experience focusing on managing and/or supporting technical projects required. Proficiency in MS Office applications is required, especially with Excel and PowerPoint. Experience in customer focus, program/project management, accountability, process orientation, and strategic thinking required. Experience in process excellence and process thinking and application of tools is preferred. Six Sigma or Process Excellence certification is preferred. Negotiation skills, ability to effectively work with peers, analytical skills, and business acumen are required. Establish project success criteria and monitor activities required.