Manufacturing Engineer I

Juncos, Puerto Rico
Contracted
Mid Level

JOIN OUR TEAM!

PharmaLex is a highly successful and growing consulting company for the Healthcare industry around the world. PharmaLex offers professional development, plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm, and diligence.

Location - Juncos, PR 

Requirements

  1. Process and Computerized Systems Validation
  2. Experience in FDA regulated industries
  3. Excellent verbal and written communication skills (English and Spanish).

Education Required: Bachelor's degree in Engineering 

Years’ Experience Required: 1-3 years

JOB DESCRIPTION

​​​​​​​Plan, write, implement, and review the Computer Systems Validation documentation. Make sure that all computer-based systems are operating as intended (with documents to prove it) and meet regulatory requirements. Determines systems software requirements. Work across a variety of software lifecycle activities as determined by project needs. Generate and execute qualification protocols and reports. Organize and maintain project status progress detail. Work with process owners to address process changes to existing work instructions and/or standard operating procedures.

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.

PharmaLex is an Equal Opportunity Employer.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.

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