Job Title: Validation Engineer

 

Job type: Direct hire

 

Location: Los Angeles, CA 90061

 

Experience required: 6 + Years min

 

Visa requirement: Only US citizens and Greencard holders

 

Skills:

Strong manufacturing experience, pharmaceutical experience ideal, manufacturing experience a plus, engineering experience a plus, experience implementing manufacturing equipment from acquisition to validation process, manufacturing engineers a plus, equipment engineers a plus, quality engineers a plus, software equipment installation a plus, validation experience ideal

 

Salary: $80,000 to $100,000 per annum

 

Company Profile;

Standard Homeopathic Company, a well-established pharmaceutical manufacturing company has an exciting opportunity for a Validation Engineer III. Our company is over 100 years old and robustly growing.



Summary:

Validation engineers are responsible for testing (measure, analyze, and verify specifications) the equipment, processes, and systems used to develop or manufacture pharmaceutical products.



Essential Duties and Responsibilities include the following.



•    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/CSV), 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.

•    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.



Education: Bachelor's degree in Engineering, Biology, or Chemistry is the minimum qualification

Experience: Minimum of 4-7 years of validation experience in a pharmaceutical, homeopathy, nutraceutical, dietary supplement manufacturing company with tableting experience.



Knowledge, Skills and Abilities:

•    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. Able to communicate progress effectively.

•    Disciplined to consistently follow Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), and safety precautions.



We offer a comprehensive benefits package including Medical, Dental, 401K, PTO, and holiday pay.