Vacancy expired!
- 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 equipment’s is must
- 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 equipment’s 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.
Vacancy expired!