Skip Navigation

Sr Scientist / Sr Scientist II - Cleaning Validation

Category Technical Services City Plymouth State Minnesota

The Sr. Scientist - Cleaning Validation position is responsible for the oversight and implementation of cleaning validation activities in compliance with regulatory requirements and industry best practices. This position will lead and oversee the implementation of the cleaning validation program for commercial and development production of pharmaceutical products.

Essential Job Duties:

  • Provide leadership and work oversight to cleaning validation scientist(s).

  • Lead the Upsher-Smith Cleaning Validation strategy. Generate and revise cleaning validation protocols, assessments, SOPs, risk assessments and reports.

  • Create cleaning validation programs for new pharmaceutical manufacturing and development space (facility, rooms, equipment). Develop CIP cleaning programs and validation systems for new manufacturing equipment and/or facility.

  • Implement new cleaning agents.

  • Perform cleaning validation execution, taking initiative and getting involved on the manufacturing floor to execute or oversee execution of cleaning validation activities. Strong focus on communication and building networks with manufacturing, engineering and Quality Assurance partners to collaborate and resolve cleaning challenges.

  • Investigate and resolve cleaning validation deviations. Implement change controls and CAPAs as required.

  • Represent Cleaning Validation in cross-functional project teams. Support global initiates and work with functional managers to implement best practices, resolve cleaning issues and drive continuous improvements.

  • Participates in inspection readiness activities and presents cleaning validation subjects in regulatory inspections. Ensures cleaning validation work is performed in compliance with agency regulations.

  • Support equipment and process validation activities, as needed, to support the Technical Service department and corporate objectives.

Requirements - Sr. Scientist I:

The Sr. Scientist – Cleaning Validation requires a Bachelor’s degree in in Pharmaceutical Science, Pharmaceutics, Pharmacy, Industrial Physical Pharmacy, Chemistry, Pharmaceutical Engineering, Chemical Engineering, Process Engineering, Industrial Engineering and 5+ years’ of cleaning validation experience in an FDA regulated industry (e.g. pharmaceutical), including cleaning validation protocol and SOP execution. A Master of Science degree in in disciplines above or other STEM discipline or an equivalent foreign degree and 3+ years' of cleaning validation experience of cleaning  validation in a  FDA regulated industry (e.g. pharmaceutical); 3+ years’ experience writing technical documents including validation plans, policies, risk assessments, protocols, reports, and SOPs required. Application of Validation Lifecyle Approach (e.g. ASTM E2500, GAMP) required.

Requirements - Sr. Scientist II:

The Sr. Scientist II – Cleaning Validation requires a Bachelor’s degree in Pharmaceutical Science, Pharmaceutics, Pharmacy, Industrial Physical Pharmacy, Chemistry, Pharmaceutical Engineering, Chemical Engineering, Process Engineering, Industrial Engineering, other STEM discipline or an equivalent foreign degree and 6+ years' of cleaning validation experience of cleaning  validation in a  FDA regulated industry (e.g. pharmaceutical); OR a Master’s degree in the above listed education disciplines and 8+ years’ of cleaning validation experience FDA regulated industry (e.g. pharmaceutical), including cleaning validation protocol and SOP execution. 3+ years’ experience writing technical documents including validation plans, policies, risk assessments, protocols, reports, and SOPs required. Application of Validation Lifecyle Approach (e.g. ASTM E2500, GAMP) required.

Other Requirements:

Thorough understanding of CLV limit calculations, ADE and TOC limits. Ability to read/interpret batch records, process development and characterization documents. Ability to work as part of a high performing team and collaborate effectively with staff at all levels. Understanding of a matrix approach  and period monitoring of a cleaning validation program. Ability to establish highly functional relationships with diverse personalities both within and outside the company. Demonstrated ability to manage multiple activities and meet timelines while maintaining a high level of organization. Ability to interpret and relate validation standards for implementation and review to functional areas. Demonstrate flexibility in problem solving, providing risk-based options toward challenges for executive review and decision making.


Upsher-Smith Laboratories, LLC. is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, LLC. will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.
Job ID 8110

Join Our Talent Community

By joining our talent community, you are signing up to receive job alerts for the categories and locations you choose. Fields with an asterisk are required.

Areas of InterestSearch for a category and select one from the list of suggestions. Search for a location and select one from the list of suggestions. Finally, click “Add” to create your job alert.

  • Technical Services, Plymouth, Minnesota, United StatesRemove

Upsher‐Smith respects your privacy. We will not sell or rent your email address to any third party. You may opt out of receiving job posting alerts at any time.