Validation Engineering Specialist - Co-Op

at  Thermo Fisher Scientific

SUMMARY:

Provides specialized validation knowledge and information, which is directly required to support operations and clients. Completes all protocols related to the validation of equipment, processes, and new products and reviews all finished reports prior to final approval. Ensures documents conform to all Patheon Standard Operating Procedures (SOPs), client requirements, and Good Manufacturing Practices.

EDUCATION:

A high school diploma/General Educational Development (GED) Certificate is required
Currently enrolled in a Coop B.Sc. Program in Computer Science, Mechanical Engineering, Chemical Engineering, Life Science, or related fields

EXPERIENCE:

Previous experience in a validation or science-related environment.

KNOWLEDGE, SKILLS AND ABILITIES:

Strong written and oral skills. Detail oriented and organized, with a high degree of accuracy and thoroughness. Excellent interpersonal skills, communication and organizational skills. Strong judgment, decision making and trouble shooting skills. Ability to multi-task, meeting tight deadlines in a fast paced environment. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English Language.

PHYSICAL REQUIREMENTS:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/lab office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.

DISCLAIMER:

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as a comprehensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

• Prepare validation protocols, e.g. Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for more complex equipment, facilities, and computer systems.
• Execute protocol, report deviations, and participate in deviation analysis and resolution.
• Participate in the data specifications and format review process.
• Maintain site computerized system inventory list.
• Conduct 21 CFR Part 11 assessment and Data Integrity assessment for computerized systems
• Maintain a safe working environment and report potential hazards.
• Maintain documentation archiving.
• Collect, review, and verify data.
• Maintain cleaning program and trending cleaning results.
• Coordinate validation activities with other supporting departments.
• Coordinate samples collection and delivery to lab
• Support special projects (as required)