- Job Title
- Validation Engineer
- Job ID
- CARROLLTON, TX 75006-6623
- Other Location
Swiss American CDMO LLC is a topical drug and medical device manufacturing company founded to provide cutting-edge topical skin care technologies to selected markets. Our business strategy consists of development, manufacturing and superior customer service to contract manufacturing customers worldwide. A strong team approach to serve our customers is the basis of our mantra – “Partnering to deliver service through quality, integrity, and commitment.” Are you passionate about Service Excellence, Results, Integrity and Leadership? These are the core attributes we are looking for at Swiss-American CDMO, LLC.
Under the supervision of the Quality Control Manager, the Validation Engineer is responsible for writing, gaining approval, and tracking all validation activities at Swiss American Products, Inc. (SAP).
Essential Duties and Responsibilities:
- Write, obtain approval, and help execute all compounding, stability, packaging, process and equipment validations (others as needed).
- Coordinate validation activities with production to assure that validations are carried out accurately and on schedule.
- Write and obtain approval of all post validation reports, including interim and final reports.
- Ensure that all validation activities are performed in accordance to SAP SOP’s and FDA/GMP guidelines.
- Track and log validation activities to ensure full compliance with FDA regulations.
- All other duties and responsibilities as assigned by the Quality Control Manager
Limits of Authority: Interprets work situations and expectations, handles issues which conform to Company policy and past practice, and refers extraordinary situations to the Quality Control Manager for guidance when necessary. Appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
- Bachelor’s degree or Associates degree with relevant experience.
- Must have a working knowledge of validation activities in an FDA regulated environment (OTC Drug, Medical Device, Pharmaceutical Drug)
- Must be able to explain processes and effectively implement processes as outlined by SAP protocol.
- Must be able to adequately understand SAP protocol and apply to various production processes as it applies to specific procedures.
- Must be able to deal with a variety of situations, including stopping production if the continuation of production would compromise the integrity of the finished good.
- Knowledge of Microsoft Office Business Suite and Internet software.
- Good working knowledge of Microsoft Excel or Minitab desired.
We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive annual salary, an extensive benefits package including paid time off, medical, dental and vision benefits, 401K plan with company match and future growth opportunities within the company. Plus, we work to maintain the best possible environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning, and culture.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.