Manager, Validation Engineering (Onsite)

at  Thermo Fisher Scientific

JOB DESCRIPTION

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

QUALIFICATIONS

• Ability to train, mentor, and coach others.
• Experience and interpretation of statistical process control
• Good communication (oral and written), organizational and time management skills.
• Support technical activities at the plant level to ensure regulatory compliance and efficiency of facilities, equipment, and processes.
• Apply cGMP regulations and guidelines to all aspects of validation / qualification activities.
• Professional knowledge and experience with gap analysis, GxP requirements, FMEA, and FDA/EMEA requirements applicable to the pharmaceutical industry. .
• Experience with supervision, all types of validations, maintaining processes and equipment in a validated state.

EDUCATION AND EXPERIENCE:

Basic Qualifications:
Bachelor’s Degree in Science or Engineering and at least 6 years of validation experience, prefer at least 1 to 2 years of management experience. Shown success working across organizations in highly matrixed / team environment. Validation experience with startup and maintenance of automated pharmaceutical manufacturing systems. Equivalent combinations of education and experience may be considered.
Familiarity with applicable US and worldwide regulatory requirements for the pharma industry

• Manage Risk Analysis, Scale-up/Transfer trials, and support complex Validation activities.
• Support production staff, including assessment of investigations, implementation of path forward, and determination of product impact.
• Supervises daily operations of the Validation (Process/CPV/Cleaning/ Equipment/Utility/Automation/Laboratory) team.
• Responsible for all validation activities inclusive of the site validation master plan
• Responsible for the cleaning validation program to ensure best practices in developing CIP and manual cleaning procedures.
• Responsible for supporting manufacturing of pre-commercial development batches and identifying areas of process improvements.
• Planning, coordinating, and leading the team to meet project requirements and budget targets are adhered to.
• Daily solving, process optimization, technical review of process issues and increased efficiency via continuous improvement measures.
• Assists with the development and management of related policies, procedures, and protocols to ensure consistency and efficiency. Assures that activities are conducted in compliance with US and EU regulations and EHS requirements.
• Sets measurable and achievable individual goals; leads and motivates team to achieve their targets.
• Reviews and approves documents prepared by the team. Writes protocols, batch records, assessments, change controls, and summary reports as needed. Collects samples, analyzes data, and coordinates support resources, as needed.
• Maintains inventory of GxP related equipment and associated periodic review activities.