Validation Engineer I/II

Validation Engineer I/II

Requirements

• Bachelor’s degree in Chemical Engineering, Industrial Engineering, Biomolecular Engineering, Mechanical Engineering, or related scientific field.
• One (1) to three (3) years of experience as a Validation Engineer, Equipment Specialist, Engineer, or related role in the pharmaceutical/biotechnology industries for Validation Engineer I.
• Three (3) to five (5) years of experience as a Validation Engineer, Equipment Specialist, Engineer, or related role in the pharmaceutical/biotechnology industries for Validation Engineer II.
• Demonstrated ability to work in a team environment.
• Demonstrated ability to learn through On-the-Job Training (OJT).
• Strong communication skills within all levels of an organization for Validation Engineer II.
• Technical Writing; Literacy in Engineering Documentation review/interpretation; Performing Equipment/System Risk Assessment for validation testing; Protocol management in development; field execution; deviation resolution and authoring and closure of final reports.
• Ability to read and interpret English documents such as safety rules, operating and maintenance instructions, procedure manuals, batch and production records.
• Ability to write routine reports and correspondence.
• Ability to speak effectively before internal groups or employees of organization.
• Efficient and effective deductive and inductive critical thinking and problem-solving skills required.
• Strong time management skills and an ability to multitask in a face paced environment. Ability to deliver consistent high-quality documentation paying attention to detail and thoroughness relative to SOP requirements.
• Ability to quickly grasp complex technical concepts and make them understandable and corollary in text and graphics.
• MS Excel and spreadsheet creation and analysis.
• Ability to add, subtract, multiply, divide, and convert in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

Responsibilities

• Act as responsible Subject Matter Expert in drafting, execution, and review/approval of validation studies/reports.
• Conform to all cGMP requirements for documentation and data integrity.
• Validation support of Quality processes (Change Control; Deviation etc.).
• Support risk and impact assessments pertaining to validation work processes.
• Support generation and/or review/revision to Engineering/Validation Specifications (URS, FRS, DDS etc.).
• Review and update department SOPs as required.

Preferred Qualifications

No preferred qualifications provided.