Process Development Scientist

Education: Doctorate degree or Master degree and 5 years of Scientific experience or Bachelor degree and 6 years of Scientific experience. Attributes (i.e. - preferred qualifications): Position # 1 Working knowledge of pharmaceutical/biotech processes. Familiarity with validation and documentation processes in a highly regulated environment. Ability to operate specialized laboratory equipment and computers as appropriate. 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 o Establish Testing Strategies o Design / Development of Characterization Protocols o Technical Reports Development o Validations, and technical reports- To support SATs executions, document generation and challenge validations strategies. o 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: o Basic technical report writing and Validation Protocol Writing o Verbal communication o Basic technical presentations o Personal Organization o Dealing with and managing change o Technical (Equipment Specific) o Analytical Problem Solving o Computer Literacy o Schedule development o Facilitation o Collaboration o Basic project management o 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: o Negotiation, persuasion and facilitation Collaboration o Project cost development o Conflict Resolution o Schedule and resources loading development Flexibility to work off-hours Position # 2: Experience in Technology Transfer, pharmaceutical, medical devices, and biotechnology in manufacturing, inspection, and packaging processes. Meticulous, Committed, Skilled, Proactive, Risk-Taking, Structured, Excellent Interpersonal Skill, Energetic, Solution Oriented. Provides analytical skills and ability to understand the big picture in complex environment. Working cross functionally and building collaborative working relationships. Ability to manage, development, implementation, and adherence to processes. Strong verbal and written communication skills, emotional intelligence, and decision maker. Able to work under pressure. Good organization skills and team worker. Knowledge of GXP for Pharmaceuticals, Biotechnology, and Medical Operations. Proficient in the preparation of technical reports and business/scientific presentations. Knowledge in raw materials, in-process controls, packaging material, labeling, and finished product variables. Knowledge in Pharmaceutical and Biotechnology equipment. Fully Bilingual. Interface with Upper and Middle Management. Determines and pursues courses of action necessary to obtain desired functional results. Acts as an advisor to staff members to meet schedules. Provide group technical guidance. Participate in global cross-functional teams, working effectively in a highly matrixed team environment to advance programs. Able to develop solutions to routine technical problems of limited scope. Knowledge in pharmaceutical product commercialization and lifecycle management. Job Types: Full-time, Contract Pay: $48.00 - $50.00 per hour Schedule: 8 hour shift Day shift Monday to Friday Overtime Weekends as needed Ability to Relocate: Juncos, PR 00777: Relocate before starting work (Required) Work Location: In person