USCIS NOTICES | hubot-tri-pac-inc

Position Opening

Job title: R&D Chemist
Job location: South Bend, IN
Number of positions: 1 opening.
Job duration: Permanent position, Full time, Mon - Fri, 40 hours per week.
Job Description: Develop new cosmetic, personal care and OTC formulations and products, including researching and selecting raw materials, creating formulas that comply to all project guidelines. Establish product specifications and procedures as required for R & D projects. Support scale-ups from prototype to commercial manufacture following GMP (Good Manufacturing Practices). Maintain accurate records of batch formulations, modifications, and stability data. Initiate, develop, and create innovative products to expand the R&D formulation library and enhance customer presentations. Perform, monitor, and document pre-stability and stability testing on R&D batches to ensure product integrity. Calibrate R&D Lab Equipment such as FTIR, viscometer, pH Meter. Conduct research on new technologies to be used in product development of Skin Care products.
Education and Experience required: Bachelor's degree or equivalent in Chemistry or Pharmaceutics or related field plus 2 year’s experience in job offered or as Scientist or Analytical
Chemist or related field. Prior work experience must include 1 year experience using FTIR, viscometer, pH Meter. Developing OTC formulations.
Mail resume to Penny Camparone c/o Hubot, Inc d/b/a Tri-Pac, Inc, 3333 North Kenmore St, South Bend, Indiana 46628. Ref: TP-1.

Position Opening

Job title: Sr. Validation Engineer
Job location: South Bend, IN
Number of positions: 1 opening.
Offered Salary: $109,117 Per year.
Job duration: Permanent position, Full time, Mon - Fri, 40 hours per week.
Job Description: Perform qualification of manufacturing equipment, facility and utility systems (including CIP/SIP qualification), cleaning validation, computer system validation and process validation. Draft qualification protocols and summary reports, field execution, and data analysis. Develop and manage complete validation lifecycle documentation including User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Design and Software Design Specifications (DDS/SDS). Support the development and execution of FATs, SATs, DQ, IQ, OQ, PQ, and other relevant life cycle documents leveraged to support validation effort. Perform validation assessments for proposed system changes, execute risk-based evaluations, and ensured adherence to GMP regulations impacting validation requirements (e.g. 21 CFR 210,211,701,710,720,740, 820).
Education and Experience required: Bachelor’s degree or equivalent in Chemistry or Pharmaceutical Science plus 5 years progressive experience in job offered or as QC Analyst or related field. In lieu of Bachelor’s degree and 5 years’ experience, will accept Master’s degree in Chemistry or Pharmaceutical Science plus 2 years’ experience in job offered or QC Analyst or related field. Prior work experience must include 2 years’ experience in Facility/Equipment/Utility Qualification, Cleaning/Sterilization Cycle Development, Cleaning Validation, computer system validation and Process Validation. Development and execution of FATs, SATs, DQ, IQ, OQ, PQ.
Mail resume to Penny Camparone c/o Hubot, Inc d/b/a Tri-Pac, Inc, 3333 North Kenmore St, South Bend, Indiana 46628. Ref: TP-2.

Position Opening

Job title: Validation Engineer
Job location: South Bend, IN
Number of positions: 1 opening.
Job duration: Permanent position, Full time, Mon - Fri, 40 hours per week.
Job Description: Perform IQ/OQ/PQ validation testing for equipment, utilities, and cleanroom environments. Coordinate with QA, Engineering, and Maintenance to maintain validated system states. Assist with Change Control and CAPA processes for system improvements. Develop and execute commissioning, qualification, and validation protocols for required equipment and systems. Prepare and maintain comprehensive documentation, including validation protocols, plans, reports, and standard operating procedures. Identify and assess risks associated with CQV activities and develop effective mitigation strategies. Conduct environmental monitoring for Temperature, Relative Humidity, and Differential Pressure. Develop and execute validation protocols; ensured compliance with cGMP and 21 CFR Part 11. Calibrate HVAC and process equipment per SOPs.
Education and Experience required: Bachelor’s degree or equivalent in Chemistry or Pharmaceutical Science plus 6 months experience in job offered or as QC Analyst or related field. Prior work experience must include 6 months experience in CQV activities, Calibrating HVAC, IQ/OQ/PQ validation testing, compliance with cGMP and 21 CFR Part 1.
Mail resume to Penny Camparone c/o Hubot, Inc d/b/a Tri-Pac, Inc, 3333 North Kenmore St, South Bend, Indiana 46628. Ref: TP-3.

Position Opening

Job title: Quality Control Chemist
Job location: South Bend, IN
Number of positions: 1 opening.
Job duration: Permanent position, Full time, Mon - Fri, 40 hours per week.
Job Description: Conduct quality assurance testing of reagents using UV spectrometry and pH meters to ensure reliability. Perform specific routine analysis of samples of raw materials, in process, and finished products according to established test procedures. Perform analysis using HPLC, GC, FTIR, UV-Vis, Karl Fischer, Complexometric Titrations, wet chemistry, and numerous other analytical methodologies/ techniques. Develop Analytical test methods and conduct Technical Method transfers. Research new analytical technologies to support the new product development. Maintain records in compliance with GMP, FDA, ISO, or other regulatory standards. Perform root cause analysis on out-of-specification results and recommend process improvements. Prepares reagents, standards, and solutions and may monitor and verify quality in accordance with statistical process and other control procedures.
Education and Experience required: Bachelor's degree in Chemistry or Pharmaceutical Science plus 1 years experience in job offered or as Analytical Chemist or related field. Prior work experience must include 6 months experience using UV spectrometry, pH meters, Complexometric Titrations, HPLC, GC, FTIR, UV-Vis, GMP.
Mail resume to Penny Camparone c/o Hubot, Inc d/b/a Tri-Pac, Inc, 3333 North Kenmore St, South Bend, Indiana 46628. Ref: TP-4.