Validation Engineer II - LYN00017

Description

At Berlex, we take pride in knowing that our work is an affirmation of life. It stems from our commitment to advance patient care and to shape the future of medicine. It also connects us to the many lives we serve in the oncology market. As an affiliate of Schering AG, Germany, a global, research-based pharmaceutical company, our purpose is to bring diagnostic and therapeutic innovations to the healthcare community. With a vast global network, a robust product pipeline and US revenues exceeding $1 billion, we offer the opportunity for career fulfillment and the chance to make life the best it can be.

 

The Validation Engineer II will be responsible for developing and implementing process validation master plans, authoring protocols, executing protocols and writing final reports for process validations. The candidate will also be responsible for authoring and revising validation SOPs and responsible for investigating deviations, assessing changes to validated processes and determining/proposing appropriate validation requirements and implementing those requirements. Additionally, lead cross-functional teams (Validation, Process Development, Production, QA) to identify process validation strategies requirements, critical process parameters, critical quality attributes and acceptance criteria. The candidate should demonstrate strong technical writing skills and contribute to investigations of Manufacturing deviations as it is related to Validation and identify areas of improvement/development for the process validation program at Berlex.

 Qualifications

* Experience developing and/or manufacturing with Fermentation and Purification processes for yeast expression systems.

* Experience with statistical design of experiments.

* Experience with commercial production of biologics.

* B.S Science/Engineering required. B.S/M.S Chemical Engineering preferred.

 

As a member of the Berlex team, you'll find an environment that celebrates diversity and welcomes the open exchange of ideas and individual perspectives.  We are proud to offer an attractive salary along with a generous benefits package designed to support the needs of you and your family while addressing work/life balance issues. To learn more about Berlex or to apply online, please visit our website at www.berlex.com.  EOE/AA/M/F/D/V.

 

 

TO APPLY ONLINE:  Click on http://www.berlex.com/html/career/search/index.html, and you'll reach the page "Search and Apply for Jobs."  In the "Job Search" box, find the "Keyword or Job Number Search Field" and enter LYN00017 and hit "Search."  Then, in the Job List under "Job Title", click on Validation Engineer II  WA - Lynwood.  Review the job description and hit "Apply Online" to complete the application process.