Spokane, Washington, USA
28 days ago
Validation Specialist

Silgan Dispensing Systems is a growing global company with operations in over 10 countries where we develop dispensing solutions for iconic brands in industries like fragrance, healthcare, home/garden, cosmetics, and so much more. The dispensers we manufacture can be found on some of your favorite products. When you spray your kitchen counter, wash your hair, or put on your favorite cologne, there’s a good chance you’re using a dispensing product we make! We create innovative solutions for our customers and their consumers with strong aesthetic and technical performance with a focus on sustainability.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Design and draft validation protocols for processes and equipment.Design and draft calibration protocols for equipment.Create draft validation protocols.Execute validation and calibration documents.Implement FDA/ISO documentation for equipment and/or processes including SOPs and preventive maintenance documents and forms.Work to ensure that calibrations are fully integrated to demonstrate that equipment consistently functions as intended to maintain regulatory compliance for the facility.Perform and document experiments to demonstrate that equipment and processes consistently function as intended to maintain regulatory compliance of the facility.Write draft reports based on data gathered during execution of validation documents.Support Engineering in compliance with FDA/ISO regulations.Assist with writing Standard Operating Procedures (SOPs), Preventive Maintenance procedures, and other documents for equipment and processes as needed.Consult with other departments on FDA/ISO regulatory compliance as requested.Perform initial reviews of equipment usage to determine if systems need to be re-validated or calibrated.Travel between sites to provide Validation Support as needed.Evaluate external calibration protocols and schedule external vendors for maintaining calibration needs of the organization.Evaluate external validation protocols.Ensure compliance with cGMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.Adhere to company safety requirements.Regular attendance.All other responsibilities as required.
 

MINIMUM REQUIREMENTS:

Bachelor’s degree in science, Engineering, or a related field, or an equivalent combination of education and experience.Three years’ experience in Validation.One year’s experience in Calibration.Knowledge of the Scientific Method.Knowledge of ISO and FDA requirements for GMP/GLP practices.Experience working in a FDA regulated manufacturing facility.Ability to work independently with minimal direction.Ability to prioritize workload to meet established deadlines.Familiar with Chemistry, Microbiology, and Engineering terminology.Ability to perform basic statistical calculations and analysis.Experience creating and maintaining documentation and proficient in Microsoft Office.External qualification to a recognized certifying organization for calibrations is preferred.

PHYSICAL REQUIREMENTS:

Regularly required to talk and hear.Required to sit for 3-4 hours at a time.Frequently required to walk and stand.Occasionally lift to 25 pounds (12 kg).Fine motor control to grasp small objects.Vision includes close vision, color vision and the ability to adjust focus.

Pay Range: $68,950 - $79,724

(Salary Non-Exempt)

Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.

LIMITATIONS AND DISCLAIMER

The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position.

All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees.

This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow any other job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws.

Requirements are representative of minimum levels of knowledge, skills and/or abilities. To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently. Continued employment remains on an “at-will” basis.

Silgan is an Equal Opportunity Employer. We consider applicants for all positions without regard to race, color, religion, sex, national origin, age, marital status, or the presence of a disability, which would not prevent the performance of essential job duties with, or without reasonable accommodation of any other protective status.

Silgan is a drug-free workplace.

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