Cleaning Validation Engineer

4 weeks ago

Novato, United States Pharmatech Associates Full time

* We all contribute to the success of our clients. Your input will be heard, encouraged and valued. * As a consultant with Pharmatech you will gain invaluable experience from project to project. * Your coworkers are a group of highly intelligent and motivated leaders. There will always be someone to learn from. * We take great pride in offering competitive compensation packages to attract top talent. * No internal politics A culture that thrives on true collaboration. Location

Novato, CA We are looking for a **Cleaning Validation Engineer** to join our consulting team and provide market leadership to the Life Science industry. This is a 6

12 month contract position located in Novato, CA * Design and coordinate cleaning validation activities. * Prepare and execute protocols and reports for cleaning development and validation. * Perform investigation of deviations / discrepancies. **Job Functions** * Design and develop cleaning validation protocols for products and manufacturing equipment, including steaming studies * Provide technical support to cleaning activities associated with the manufacturing process. * Develop a strong documentation package, involving pre-commissioning/commissioning of equipment, Qualification and documentation * Support cleaning validation program and activities, including re-validation and validation discrepancy reports * Designs and supports the implementation, i.e. provides training, of cleaning strategies for product transfer projects and product development projects. * Investigates and conducts troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non validated or under development cleaning procedures. * Supports the establishment and/or enhancement of cleaning practices. * Reviews and approves Manufacturing Cleaning Working Instructions and Forms. * Supports the periodic review of cleaning validation studies. * Performs successful and on time resolution of incidents and deviations related to cleaning validation exercises. * Issues Change Controls required for the implementation of cleaning procedure changes, as needed. * Trains manufacturing and QC/QA personnel on cleaning validation documentation. **Qualifications** * Bachelor's in Science, Engineering or related discipline plus 5 years of professional experiences in cleaning validation in the pharmaceutical and/or biotechnology industries. * Proficient knowledge of cleaning validation, continuous process improvement and troubleshooting processes. * Fluent in drafting and executing re-validation protocols and validation discrepancy reports required * Ability to design and develop cleaning validation protocols for products and manufacturing equipment, including steaming studies/procedures is required * Proficient time management skills, planning and organization capabilities. * Proven leadership & teamwork skills, self starter, results oriented and build and maintain strong relationships with multiple groups. * Proven assessment, analytical and problem-solving skills. * Proficient in cGMP's, OSHA and FDA Regulations as it applies to pharmaceutical industry. *Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.*

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