Skilled Validation Engineer

Job Summary:

This position is in the Quality Engineering organization at the aseptic pharmaceutical manufacturing facility. The incumbent will work individually, supporting another engineer, or as part of a team, experienced in chemistry laboratory instrumentation, specifically, an osmometer. MUST NOT BE ALLERGIC TO PENICILLIN OR CEPHALOSPORINS.

Responsibilities:

• The individual will be responsible for supporting a range of validation disciplines which may include equipment, facility, software, cleaning, and process validations.
• In addition, the individual may be requested to execute feasibility, evaluation, or exploratory studies to support new products or processes.
• The individual will be responsible for collecting requirements, developing a project validation plan, and executing to completion.

Qualifications:

• Minimum of a BA or BS preferably in the Life Sciences/Engineering/Chemistry or other job-related discipline.
• A minimum of 2 years previous experience with a pharmaceutical or biotech company.
• At least 1 year of validation experience
• Experience with equipment (water and utilities), including familiarity with basic microbiological and chemical water testing a plus.
• Must have the ability to prioritize and execute multiple project tasks.
• Knowledge of the basic principles of validation across multiple disciplines
• Ability to solve routine validation issues with minimal assistance.
• Ability to learn quickly through multiple channels.
• Must be able to work as a collaborative team member.
• Ability to clearly communicate with respect to technical or project management issues, both verbally and in written form.
• Must possess strong documentation skills and be able to follow specific instructions.

Skills:

• Team Player
• Excellent Communication