- Job Title
- Process Engineer
- Job ID
- CARROLLTON, TX 75006
- Other Location
Swiss American CDMO LLC is a topical drug, skincare, wound care, and medical device developing and manufacturing company founded to provide cutting-edge topical skincare 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. To see all of the opportunities currently available with Swiss-American CDMO, please follow this link in addition to exploring the opportunity that you have already selected below - www.swissamericancdmo.com/careers.
The Process Engineer position functions as the liaison between RID, Quality, and Compounding. This role is responsible for developing and optimizing production processes that efficiently enable product scale-up, as well as facilitating technology transfer from RID into manufacturing. The Process Engineer will also manage compliance with the Quality Management System and lead activities as required by our environmental, health, and safety policies.
Essential Duties and Responsibilities:
- Successfully transfer newly developed formulations from RID to manufacturing by converting lab processes and observations into practical, appropriate, and scale-able production processes. This includes the release and translation of thorough work instructions; and the construction of batch instructions and process control parameters that are clear, minimize variation, and specific to batch size and manufacturing vessels, as required.
- Manage pilot/trial/first production scale-up batches and processes including coordination with operations for batching and filling. Serve as technical liaison with validation specialists for OTC documentation.
- Transcription of the defined RID batching process for bulk manufacturing, including the identification of mixing vessels and compounding equipment needed for commercial scale-up. Develop tools to formalize the scale-up process.
- Interface cross-functionally with research, innovation and development, sales, marketing, supply chain, quality, and manufacturing teams to define technical requirements, develop processes, and prepare documentation.
- Development of existing and new manufacturing processes (manage, communicate, document, analyze, train).
- Perform upstream processing and ensure scalability of operations during process development.
- Identify new technologies to improve efficiency, enhance quality, and reduce costs of existing and new products.
- Train Compounders and Supervisors on new processes and procedures. Develop and monitor key metrics - including efficiency, right the first time, water usage, etc.
- Assist VP, RID with the investigation of the IP landscape for confirmation of freedom to operate with respect to the processes being developed.
- Support all Company initiatives as identified by Management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Bachelor’s degree (B.A.) from four-year college or university in a relevant discipline; plus 5-7 years engineering experience in cosmetics/skincare/beauty, OTC drug, and medical device manufacturing.
- Laboratory experience in formulation scale-up 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.