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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 Previous experience supporting production manufacturing lines.
Problem solving methodology knowledge (Ex.
Yellow/ Green Belt).
Project management and/or project owner experience.
Process and CSV validation knowledge.
Education Required: candidates need an Engineering Degree Years' Experience Required: More than 5 years' experience in an Engineering position in medical device environment.
JOB DESCRIPTION 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 Autonomy: Seasoned individual contributor.
Works independently under limited supervision to determine and develop approach to solutions.
Coaches and reviews the work of lower level specialists; may manage projects / processes.
Organizational Impact: May be responsible for entire projects or processes within job area.
Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties .
Makes improvements of processes, systems or products to enhance performance of the job area.
Analysis provided is indepth in nature and often provides recommendations on process improvements.
Communication and Influence: Communicates with senior internal and external customers and vendors.
Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.
Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area.
May manage projects, requiring delegation of work and review of others' work product .
Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
May have practical knowledge of project management. 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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