Scientist - Denver, CO

General Summary

Completes projects that provide technical support for production operations and validation testing of production systems. Completes process validation, equipment/systems and utility qualification, and supports product development projects with minimal supervision as required.

Essential Duties

Completes projects that provide general technical support for production operations and validation testing of production systems. Completes process validation, equipment/systems/utilities qualification, and supports product development projects with minimal supervision. Ability to operate in a dynamic environment with several projects and priorities.

Description of Essential Duties

1. Write equipment qualification reports, process validation reports, technical reports, and validation master plans.

2. Perform monitoring, sampling, and testing to validate equipment, systems, and processes per

validation protocols. Assist in the generation of user requirements, functional specifications, and design specifications as required for equipment qualification projects.

3. Coordinates validation activities with other functional groups. Executes the strategies and testing required to validate equipment, systems, and processes per validation protocols.

4. Identify and execute activities for change control system.

5. Assist with laboratory or pilot scale batches and manufacture of production experimental scale batches.

8. Review and verify data generated in laboratory notebooks and technical documents.

9. Tabulate and perform statistical analysis of all study data. Present conclusions with clear, logical explanations and justifications via technical reports.

10. Provide technical consultation and support to both Technical Services and external departments as required.

Education: Bachelors

Experience Type: Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering, or related life science field with a minimum of 4 years’ experience product development/manufacturing, process/equipment engineering, or process validation in a regulated environment, including familiarity with equipment/process government regulations (e.g. camp’s, NDAs, ANDAs);

Travel Requirements: No Travel

Physical Requirements: Sitting: 34 - 66% (Frequent). Standing (Moving About): 34 - 66% (Frequent). Listening: 34 - 66% (Frequent). Near acuity (vision): 34 - 66% (Frequent). Speaking: 34 - 66% (Frequent). Use of computer keyboard / mouse: 67 - 100% (Constant). Color determination: 1 - 33% (Occasional).

Mental and Motor Requirements

Computer Skills: 67 - 100% (Constant). Problem Solving: 34 - 66% (Frequent). Reading / Comprehension: 67 - 100% (Constant). Verbal communication: 34 - 66% (Frequent). Writing / Composition: 34 - 66% (Frequent). Attention to detail: 67 - 100% (Constant). Advanced math calculations: 34 - 66% (Frequent). Interaction with others using professionalism and tact: 34 - 66% (Frequent). Independent decision making: 34 - 66% (Frequent).