Validation Engineering Specialist II

at  Thermo Fisher Scientific

SUMMARY:

Provide specialized validation knowledge and information, which is directly needed to support operations and clients. Complete protocols and reports related to the Continues Process Verification (CPV) of manufacturing and packaging processes (including serialization) as well as cleaning validation. Ensure documents conform to all ThermoFisher Standard Operating Procedures (SOPs), client requirements and Good Manufacturing Practices.

EDUCATION:

BSc in Chemistry, Pharmacy, Engineering, or related field.

EXPERIENCE:

Minimum 3 years’ experience in validation within the pharmaceutical industry.
Previous experience in statistical analysis is preferable.

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. Mini-Tab and data analysis knowledge an asset. 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 and execute validation protocols (new and existing clients) and writing reports.
• Review/verify data and performs statistical analysis.
• Monitor the production scheduling and coordination of validation activities as required
• Attend client meetings as validation representative.
• Provide technical/validation expertise and support to Quality Operations/Business or Project management/operations/Pharmaceutics and Process Technology (PPT).
• Document review of peer protocols and reports.
• Maintain cleaning program and trending cleaning results.
• Support equipment swabbing.
• Attend client meetings as validation representative (as required)
• Support special projects (as required)
• Maintain a safe working environment and report potential hazards.
• Perform alternating or rotating shifts (if required)