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Careers at Hyland's Validation Engineer III Los Angeles, California, USA
Hyland's is a leader in innovations that answer to the changing health needs of our modern world. We celebrate our century long commitment to making medicines that are rooted in safe and natural homeopathic remedies.
The opportunities have never been greater nor has our responsibility. Our team is quickly expanding amidst larger conversations of natural and homeopathic medicines taking center-stage, making it an exciting time for you to join us. We are looking for qualified applicants who strive to make an impact and believe in working in a higher purpose. We're excited to hear from you!
SUMMARY: The Validation Engineer III is responsible for providing technical support of validation activities and leadership within the Validation department. The validation activities include supporting the validation of equipment, systems, facilities, and processes at Standard Homeopathic/Hyland's, Inc. (SHC). Validation engineers are responsible for testing the equipment, processes, and systems used to develop or manufacture pharmaceutical products. They measure, analyze, and verify specifications of equipment and processes to ensure the highest quality products are created. ESSENTIAL DUTIES AND RESPONSIBILITIES: ● Develop and generate validation protocols associated with equipment, systems, and processes used in the SHC facility. ● Directly and indirectly support the execution of validation protocols (IQ/OQ/PQ/CVP/Automated Equipment), including the collection of samples, data, and completes protocol attachments, as requested. ● Directly and indirectly compiles and analyzes validation data, prepares reports, and makes recommendations for changes and/or improvements. ● Ensures that Validation management is notified of deviations from protocol criteria, supports the identification root causes and resolutions. ● Directly and indirectly supports the investigation of deviations, troubleshoot problems, and determines solutions. ● Coordinates the scheduling of validation protocol executions and testing with affected departments and personnel; this will include Manufacturing, Quality assurance/Control, and Maintenance. ● Accurately documents the results of protocol execution and qualification tests. ● Directly and indirectly supports the generation of SOPs. ● Directly or indirectly identify and define project and process improvement opportunities ● Support the development of project plans and timelines. ● Support the tracking of project goals and work within cross functional teams. ● Train equipment operators or other staff on validation protocols and standard operating procedures, as required. ● Provide technical review of equipment orders and consult when requested. ● Support the execution of Factory Acceptance Testing (FAT) and/or Site Acceptance Testing (SAT) on purchased equipment, when appropriate. ● Follow company policies and procedures and maintain a safe working environment. ● Oversee the activities of and provide leadership to the Validation Technician(s) and Validation Engineers I and II, as requested. ● May be required to perform other duties as assigned or as needed. SUPERVISORY RESPONSIBILITIES: This position has no supervisory responsibilities. QUALIFICATIONS: To 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. EDUCATION AND/OR EXPERIENCE: ● Bachelor's degree in Engineering, Biology, or Chemistry is the minimum qualification; Minimum of 4-7 years of validation experience preferably in a pharmaceutical company with tableting or other related industry, with 1-3 years supervisory experience preferred; or equivalent combination of experience, training and/or education. KNOWLEDGE, SKILLS AND ABILITIES: ● High energy, self-motivated, flexible in assignment, able to multi-task between multiple active projects. Able to communicate progress effectively. ● Follow pharmaceutical industry standards in generating and updating documentation such as P&IDs, material and equipment specifications, and requirement specifications. ● Ability to work under pressure and perform tasks on schedule with supervision. ● Good communication skills both oral and written. ● Disciplined to consistently follow Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), and safety precautions. PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to sit and use hands to finger, handle, or feel; reach with hands and arms. The employee is occasionally required to stand; walk and talk or hear. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision. WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is occasionally exposed to fumes or airborne particles. The employee is occasionally exposed to moving mechanical parts. The noise level in the work environment is usually moderate.
ABOUT US Hyland's is one of the leading homeopathic companies in North America, creating medicines with natural active ingredients for consumer health and wellness. Rooted in over 115 years of experience, Hyland's continues to be one of the top natural over-the-counter medicine brands that has been passed down by families for generations. All Hyland's products are prepared with the highest quality natural active ingredients and follow strict standards of preparation. Hyland's is dedicated to supporting the health and wellness of families everywhere.
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