Validation Engineer

SUMMARY: Responsible for ensuring that all products, processes, and systems meet regulatory and quality standards through rigorous testing and analysis. Collaborate with cross-functional teams to design, develop, and execute validation protocols, and generate validation reports to ensure compliance with regulatory requirements. Work Schedule: Monday - Friday 8am-5pm, OT required per project needs JOB QUALIFICATIONS: B.S. (or equivalent 4-year degree) in Engineering or Science Related Field Minimum of 5 years validation experience supporting pharmaceutical cGMP manufacturing and/or technical support operations Experience with Liquid, Solids, Medical Devices and Semisolid Dosage Forms Experience authoring, executing and summarizing validation qualification protocols Experience with Cleaning Validation including swabbing and reinstate sampling Regulatory inspection experience with external regulatory authorities Knowledge of the principles and application of statistical analysis preferred Technical writing and attention to detail required Trained and experienced on Validation (Product Life Cycle), Start-Up, Equipment Evaluation, Selection and Commissioning Extensive knowledge on Technical Investigations and Product/Process Development/Optimization. Experience in administrative techniques, Vendor Qualifications Knowledge of the principles and application of cGMP guidelines related to validation activities Time management and ability to handle multiple tasks on time Relies on extensive experience and judgment to plan and accomplish goals Computer literate • Strong conflict resolution skills Strong communication skills - verbal and written Strong collaboration and teamwork Willingness in traveling POSITION RESPONSIBILITIES: Establish validation standards, develop testing protocols, prepare equipment, document test results and maintain records for later analysis Validate new and re-validate as appropriate existing equipment used in OTC/Rx manufacturing, packaging, compose reports and make adjustments to equipment or processes that require improvement Evaluate, implement and monitor processes, operating systems, critical utilities, manufacturing and packaging equipment in accordance with appropriate regulatory agency validation requirement and current industry practices Create/edit/maintain necessary documentation that pertain to the Evaluation of the Process Qualification PPQ/Manufacturing & Packaging Equipment Qualification and the Status of the Critical Utilities (HVAC, USP DI Water Compress Air System) as well as any other utilities that affect directly the Critical Products Attributes Evaluation of the Critical Utilities, Manufacturing and Packaging Equipment calibration and maintenance monitoring during the execution of these systems Qualification Evaluation of existing and/or creation of Cleaning, Operation Procedures for the critical utilities, manufacturing and packaging equipment. Assess the availability of raw materials and their impact in a specific manufacturing process not only from the process influence but also from the safety and environmental influence of the facility related to this material Support the conversion during the “Scale Up” of any Manufacturing Process that has been developed at a small-scale process into commercially viable large-scale commercial operations Coordinate and responsible of all New Molecules transfers from R&D bench/pilot size to the manufacturing. Monitor and improve the efficiency, output and safety of manufacturing processes through observations and measurements as well as by collecting and interpreting data from other technical and operating personnel Coordinate projects directly with vendors and service providers to ensure that all validation and installation requirements are being satisfied during the execution of protocols Work closely with other specialists (including scientists) for quality control of raw materials. Measure instrument or software performance to determine if tools are performing as described for temperature mapping, and calibration activities Provide validation support for Computerized Systems including Automation and Laboratory Equipment and qualification / validation activities of Primary / Secondary manufacturing operations All other duties, as assigned PHYSICAL REQUIREMENTS: Assume responsibility for safety/environmental issues during an ongoing performance qualification of a manufacturing process Must be able to lift and carry light loads as necessary in conducting testing Weekend or long hours based on testing schedule May involve standing for long periods of time Must be able to wear proper gowning and PPE in manufacturing areas as required to meet GMP and/or OSHA requirements BENEFITS: ⦁ Medical and Dental Benefits ⦁ 401K with employer match ⦁ Group Life Insurance ⦁ Flex Spending Accounts ⦁ Paid Time Off and Paid Holidays ⦁ Tuition Assistance ⦁ Corporate Discount Program ⦁ Opportunities to Flourish Within the Company