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Engineer, Sr Cal/PM & Validation

ORGANIZATION: This position reports to the Sr. Manager of Engineering for the Strategic Reagents Manufacturing Projects Group The Engineering group is responsible for all custom process equipment.  The scope of work for each piece of equipment includes Requirements Definition, Procurement, Fabrication, Validation, and Change Management. We are currently supporting a major plant expansion at Walpole MA, and construction of a new Manufacturing plant in China.  This position may be based out of either Llanberis, Wales or Walpole, MA  SPECIFIC REQUIREMENTS: Lead the implementation of a Calibration & Maintenance system for the China project.  Define the Calibration & Maintenance requirements for process equipment, Test instruments, and facility infrastructure Manage the development and transfer of Maintenance procedures Train the China staff on Siemens Global procedures and best practices regarding Calibration and Maintenance Train the China staff in using the CERDAAC application Assist in the Validation of Automated Cleaning equipment for Walpole & Shanghai: Parts washers, Autoclaves, COP/CIP   GENERAL REQUIREMENTS: As a Senior Engineer, this position performs moderate tasks and functions in the specific Engineering field.  Identifies and resolves more complex problems and applies problem solving skills in order to deal with most situations. Demonstrates and applies a broad knowledge of Engineering field of specialization through successful completion of moderately complex assignments.  Successfully applies complex knowledge of fundamental concepts, practices, and procedures of particular areas of specialization.  Demonstrates knowledge of organization's business practices and issues. Provides general guidance or train lower level support staff   REQUIRED SKILLS: Experience working in regulated industry such as ISO 9000, cGMP.  Preferably in the Pharmaceutical or Life Science Industry. Experience in the generation and execution of validation protocols.  Preferably for custom process equipment.  Subject matter expertise in developing and managing Calibration & Maintenance activities.  Preferably in a large-scale manufacturing plant. Experience developing Maintenance procedures for process equipment, test instruments, and facility infrastructure.  Preferably experience in training the Maintenance technicians.   EDUCATION: BS in related Engineering discipline, or equivalent combination of education and experience.  Certification may be required in some areas of specialization.  EXPERIENCE: Typically 5-8 years of successful experience in related field and successful demonstration of key responsibilities and knowledge   TRAVEL: 20-25% international travel is anticipated to support training and knowledge transfer from Walpole to the China plant  
Salary Range: NA
Minimum Qualification
5 - 7 years

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