Manufacturing Engineer-Medical Device

Principal Duties and Responsibilities

• Responsible for the development, execution, and management of installation, qualification, and validation documents and protocols for process equipment
• Support a wide variety of Equipment qualifications including CNC machines
• Guide, mentor, and cross-train team members to broaden validation capabilities, including equipment and process validation
• Create change requests in windchill to support equipment moves
• Execute to project plans and schedules for work activities
• Communicate (written and verbal) with appropriate personnel from other departments

Expected Areas Of Competence (i.e., Knowledge, Skills And Abilities)

• Strong knowledge of cGMP regulations, including FDA, EMA and ISO requirements
• Experience writing and executing validation protocols and reports, including IQ/OQ/PQ documentation
• Proficiency with validation of manufacturing equipment, utilities, cleaning processes and computer systems
• Good problem-solving skills through the use of quality and statistical tools
• Able to effectively work within a cross-functional team to complete critical project tasks
• Good written and verbal communication skills
• Strong technical writing and documentation skills
• Able to independently develop and execute on project plans
• Demonstrated ability to take initiative and provide recommendations on process, procedure and training

Education/Experience Requirements

• B.S. in Engineering with a minimum of 3-year experience in validation in pharmaceutical/biotech manufacturing
• Bachelor's Degree and 0 years of relevant experience, or Associate's Degree and 2 years of relevant experience, or High School Diploma or Equivalent and 4 years of relevant experience