R&D Technician 2

POSITION SUMMARYThe mission of this role is to enable the development of manufacturing processes for combination medical devices and complex dosage pharmaceuticals. This position conducts experiments, operates and understands process and testing equipment, and collects data and observations to support process document development. The role supports compliance by following SOPs and cGMP requirements and producing accurate and detailed records of their work. The position follows all safety protocols and supports a culture of continuous improvement.This position operates under supervision from R&D engineering staff.The R&D Technician II ensures ProMed's brand, philosophy, systems, policies, and procedures are properly implemented and observed.ESSENTIAL DUTIES & RESPONSIBILITIESPosition duties and responsibilities include, but are not limited to the following:Execute process experiments, testing procedures, and production activities that generate process data and/or products for testing, ensuring development objectives are met within established timelines and quality standards.On average this should be about 70% of your time. Among other things this means we expect you to:Perform process equipment setup, teardown and cleaning procedures and ensure the systems are ready for development or production activities.Support process development experiments and document process observations.Execute product or process sample characterization testing.Produce complete and accurate records of experiments and production activities in process records and/or laboratory notebooks compliant to GDP requirements.Escalate unexpected observations to engineering or QA staff.Maintain laboratory, equipment, and instrumentation in optimal working conditions, ensuring consistent and efficient system performance and a safe working environment.On average this should be about 20% of your time. Among other things this means we expect you to:Perform routine cleaning and maintenance as required per equipment/instrument SOPsSupport well-organized laboratory and production areas including supply stocking, organization, and waste disposal.Use correct engineering controls and personal protective equipment during high-risk procedures.Document experimental results and production activities with precision and completeness, creating reliable records that support product and process quality.On average this should be about 10% of your time. Among other things this means we expect you to:* Complete GMP record entries for activities performed (e.g., equipment and cleanroom logs, test records, batch records, etc.).* Complete laboratory notebook entries in real time during experimental procedures. Ensure all entries are made to ALCOA-PLUS and GDP requirements.This job also requires performing other duties as assigned.Page BreakQUALIFICATION, EDUCATION & EXPERIENCETo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Required:* Associate's Degree + -OR- 2 to 4 years of experience in a regulated technical environment* Experience operating processing and manufacturing equipmentPreferred:Experience with hands-on technical workExperience with characterization tools such as microscopes and measurement toolsExperience in the medical device and/or pharmaceutical industryExperience with extrusion, injection molding, or wet chemistry.Chemical production experienceExperience with MS OfficeProblem-solving and critical thinking skillsStrong interpersonal, written, and verbal communication skillsClearly conveys ideas and receives information effectivelyProfessional, courteous, and friendly personalityWorking knowledge of English (verbal and written)Page BreakWORK ENVIRONMENTThe work environment characteristics described here are representative of those an employee encounters while performing the principal roles and responsibilities of this job.Duties are performed indoors.Exposure to heated/air conditioned, ventilated facilities with fluorescent lighting;Exposure to building where a variety of chemical substances are used for cleaning, and/or operation of equipment;Exposure to production areas, including pharmaceutical cleanrooms, where pharmaceutical ingredients are used.Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.PHYSICAL, SENSORY, COGNITIVE & NEUROLOGICAL DEMANDSWhile performing the duties of this job the employee will require the following capabilities:Ability to stand and walk for extended periods (up to 8 hours per day) while working in laboratory and cleanroom environments, with or without reasonable accommodationCapability to bend, stoop, kneel, and reach frequently throughout the shift to access equipment, supplies, and work surfaces at various heights, with or without reasonable accommodationAbility to lift and carry laboratory equipment, supplies, and materials weighing up to 25 pounds regularly throughout the day, with or without reasonable accommodationAbility to work in controlled cleanroom environments while wearing required personal protective equipment for extended periods, with or without reasonable accommodationCapability to perform repetitive cleaning and maintenance tasks of laboratory equipment and work surfaces throughout the shift, with or without reasonable accommodationAbility to focus visually on detailed laboratory work, measurements, and data collection for extended periods, with or without reasonable accommodation1st Shift