Process Development Specialist
hace 2 semanas
About the Role:
PharmaLex is a leading consulting company for the Healthcare industry, and we're seeking a highly skilled Process Development Scientist to join our team in Juncos, PR.
Key Responsibilities:
Develop and execute specific scientific experiments to contribute to the successful completion of goals and/or projects under general guidance of a supervisor.
Key Requirements:
Doctorate degree or Master degree with 5 years of Scientific experience OR Bachelor degree with 6 years of Scientific experience.
Responsibilities:
Conceives and designs, executes or evaluates, and interprets experimental strategies.
Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations.
Designs, monitors or conducts experimental strategies with general guidance from a supervisor.
Provides data analysis and interpretation, and assesses impact of the data on the project.
What We Offer:
Comprehensive understanding of validation protocol execution requirements.
In-depth knowledge of validation processes as applied to new equipment installations.
Ability to develop solutions to routine technical problems of limited scope.
Able to interact effectively with a variety of communication and working styles.
Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope.
Requirements:
Fully bilingual (English/Spanish).
Strong Knowledge on Vision system technologies Inspection/packaging Concepts Knowledge Development and Execution of Processes/Equipment Characterization Establish Testing Strategies Design / Development of Characterization Protocols Technical Reports Development Validations, and technical reports- To support SATs executions, document generation and challenge validations strategies.
Risk assessments and QRAES knowledge, to support risk assessments activities.
Comprehensive understanding of validation protocol execution requirements.
Strong analytical problem-solving skills for the application of scientific and engineering theory.
Working knowledge of financial analysis tools.
Ability to delegate and manage the project work of others.
Skills in the following areas: Negotiation, persuasion and facilitation Collaboration Project cost development Conflict Resolution Schedule and resources loading development Flexibility to work off-hours.
Why Choose PharmaLex:
PharmaLex is 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.
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.
PharmaLex is committed to providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm, and diligence.
Location:
Juncos, PR
Requirements:
Doctorate degree or Master degree and 5 years of Scientific experience or Bachelor degree and 6 years of Scientific experience Working knowledge of pharmaceutical/biotech processes.
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