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: 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.
- Familiarity with validation and documentation processes in a highly regulated environment.
- Ability to interpret and apply GLPs and GMPs.
- Ability to apply science based approach to production.
- 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.
- Able to develop solutions to routine technical problems of limited scope.
- Comprehensive understanding of validation protocol execution requirements. In-depth knowledge of validation processes as applied to new equipment installations.
- Demonstrated skills in the following areas:
- Basic technical report writing and Validation Protocol Writing
- Verbal communication
- Basic technical presentations
- Personal Organization
- Dealing with and managing change
- Technical (Equipment Specific)
- Analytical Problem Solving
- Computer Literacy
- Schedule development
- Facilitation
- Collaboration
- Basic project management
- Completion and follow-up
- Specialized equipment/process expertise.
- Interacts effectively with variety of communication and working styles.
- Ability to handle multiple projects at one time.
- Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope.
- Problem solving skills for the application of scientific and engineering theory
- Skills in the development of hypotheses and approach.
- 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
Job Description: To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor. Conceives and designs, executes or evaluates, and interprets experimental strategies. Provides input to new processes to generate robust and reliable data. 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 supervisor. Provides data analysis and interpretation, and assesses impact of the data on the project. Keeps current in field of scientific expertise and areas relevant to their function. Monitors field of expertise, including literature and technology development, and communicates relevant observations. May introduce advanced scientific methods. Develops and implements new and novel protocols to address specific issues. May represent the department on project teams under supervision of a senior scientific staff member. May initiate productive collaborations within and outside of the department or company. Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies. Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents. Participates in external scientific community. May assume lead role in department-wide support efforts such as safety, recruiting and committees. May develop supervisory and mentoring skills. Develops and follows timelines for completing project team work. Fully bilingual (English/Spanish).
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.