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Manufacturing Engineer II

Villalba, Puerto Rico · Biotech/Pharmaceutical

JOB DESCRIPTION

The candidate will be working on the introduction on a new product that may include:

  1. Experience in injection molding processes +PLUS
  2. Process Development and documentation
  3. Equipment validation
  4. SOP Development
  5. Special Build Documentation and Line Support

  What are the top 3 things you are looking for in a candidates experience:

  1. Experience in equipment IQ
  2. Experience in OQ (Operational Qualification) and PQ (Performance Qualification) and/or process validation
  3. Process Validation Lifecylce ( from process characterization, operational qualification to performance qualification)
  4. Preferred experience in DOE (with minitab)

 Other skills:

  1. Computer and software validation CSV
  2. SOP Development
  3. Change control of Medical Devices
  4. MES system


Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / cross functional assignments. Delivers and/or manages tasks assigned and works with other stakeholders to achieve desired results. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.  Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree in Engineering and minimum of 3-10 years of relevant experience, or advanced degree with 0 years of experience.
 

The candidate will be working on the introduction on a new product that may include:

  1. Experience in injection molding processes +PLUS
  2. Process Development and documentation
  3. Equipment validation
  4. SOP Development
  5. Special Build Documentation and Line Support

 

 What are the top 3 things you are looking for in a candidates experience:

 

  1. Experience in equipment IQ
  2. Experience in OQ (Operational Qualification) and PQ (Performance Qualification) and/or process validation
  3. Process Validation Lifecylce ( from process characterization, operational qualification to performance qualification)
  4. Preferred experience in DOE (with minitab)

 

Other skills:

  1. Computer and software validation CSV
  2. SOP Development
  3. Change control of Medical Devices
  4. MES system

*Weil Group is proud to be an Equal Employment Opportunity Employer.*

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