Description:

Responsibilities:

• To perform experiments, organize data and analyze results with minimal review.
• Plans, conducts or monitors experiments, records and organizes data, analyzes and interprets results.
• Provides input to new processes to generate robust and reliable data and/or ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations.
• Designs, monitors or conducts, and interprets laboratory experiments with general oversight of supervisor.
• Performs data analysis, provides interpretation and integrates results into the context of a project.
• Introduces new or improved methods into the lab.
• Develops and implements new protocols with minimal review.
• May serve as a representative to cross-functional teams or as a lead on department teams, with guidance.
• Recommends decisions regarding scientific-related issues.
• Demonstrates skills in problem solving at the project level.
• Demonstrates expertise and is responsible for making improvements in one or more major laboratory instruments/techniques.
• Acts as a resource in area of expertise.
• Authors complex technical documents, reports, presentations, regulatory documents, invention disclosure submissions and/or patents clearly and concisely with minimal revision.
• Assumes influential role in department-wide support efforts such as safety, recruiting and committees.
• Under general direction, has overall responsibility for a program or project of limited scope.
• Provides constructive criticism, suggestions and interpretation of results to co-workers.

Education:

• Master’s degree and 2 years of directly related experience experience.
• Bachelor’s degree and 4 years of directly related experience experience.
• Bachelor’s degree in Engineering

Preferred Qualifications:

Preparation of syringes/vials with cosmetic, particle, or solution defects for developmental studies, equipment characterization, training activities, and commercial equipment setup. Creative manual skills and mindset to develop and create defects in glass and polymer surfaces; innovative and out-of-the-box thinking for cosmetic defect creation on vials and syringes. Develop, introduce, or improve defect creation methods in the laboratory. Demonstrated skills in the evaluation of primary container defective conditions. Experience with laboratory equipment and instruments: micrometer, caliper, microscope, stereomicroscope, analytical balance, pipette techniques, and other lab tools. Knowledge in aseptic techniques. Knowledge in 5S and Lean Manufacturing concepts. Knowledge in Visual Manual Inspection Techniques and manual visual inspection experience. Knowledge in Microsoft Excel, Smartsheet, and GMP electronic documentation platforms. Knowledge in problem solving/root cause analysis tools (5 Whys, Cause and Effect Diagrams). Advanced scientific analysis and troubleshooting skills. Strong knowledge of cGMP’s. Ability to motivate and/or support the activities of others. Organized, multi-task project experience, and able to communicate and work well with other departments. Ability to work in a fast-paced environment and prioritize multiple tasks; flexible and able to handle change. Excellent interpersonal skills with ability to interact with internal and external customers. Service oriented, positive attitude, and self-motivated. Strong communication skills; fully bilingual (English/Spanish). Teamwork oriented.

Skills:

• Advanced scientific analysis and troubleshooting skills.
• Advanced laboratory work skills.
• Ability to motivate and/or supervise the activities of others.
• Must be well organized, have multi-task project experience, and be able to communicate and work well with other departments.
• Must have demonstrated skills and competencies in the following areas: Verbal communication.
• Written communication including technical writing skills, negotiation and conflict resolution, analytical problem solving and project management.
• Ability to be flexible and manage change.
• Computer literacy.
• Skills requiring the application of scientific theory.
• Creative skills in the design and performance of scientific experiments and interpretation of results.
• Strong knowledge of cGMPs.
• Fully bilingual (English/Spanish).

Work Methodology:

• 100% On-site 
• 6 months (1st Contract)
• Administrative Shift (9am-6pm and/or 8am-5pm ,Saturdays and Sundays (if necessary per business needs).
• Professional Service Contract