Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
When you’re part of the team at Thermo Fisher Scientific, you’ll do meaningful work that makes a positive impact on a global scale. Join 80,000 colleagues who bring our Mission to life each day to enable our customers to make the world healthier, cleaner and safer. You’ll find the resources here to achieve your career goals and help 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.
As one of the largest biotechnology companies in Belgium, We deliver services for the Life Science industries with specialized & differentiating technologies. HENOGEN, now part of Thermo Fisher Scientific, is based in Seneffe and Gosselies, which is home to about 400 of the company’s 80 000 employees worldwide.
For our local Validation team in Gosselies we are looking for you as aProcess Validation & Tech Transfer Expert (m/f/d)
This position is responsible for being the process validation representative and subject-matter expert to work with the external and internal clients. Will need to be a control data analyst and technical problem solver for processes entering the commercial production phase of their process life cycle. This role may have other process validation responsibilities as assigned, but will primarily retrieve process data, analyze the data, look for positive and adverse trends, correlate the findings, solve technical issues as noted by the data analysis for process improvement/ refinement, and create written reports about the exercise.
You have developed a core competency in process validation and processes from the GMP scale production during late phase clinical runs through PPQ campaigns, and commercial campaigns, as well as identifying and leading technical investigations and providing technical advisement to Manufacturing Technical Support engineers.Your responsibilities
- Perform all functions associated with process validation support.
- Author and perform the technical review of deviations and planned deviations, change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), perform activities for lot release (assess deviations and process changes).
- Make recommendations for process changes and sponsors these to the larger process team.
- Actively drive improvements for PV, OPS, and PE practices and procedures.
- Identify potential root causes of variation and deviations using a systematic approach. Expertise in use / application of variety of problem solving tools like 5S.
- Represent Process Validation on project teams and interfaces with customer technical and Quality representatives once a project has reached commercialization. Represents Process Validation on internal teams (e.g. Deviation and project management meetings).
- Participate in Customer and Regulatory Audits. Regularly interact with site and global leadership on matters concerning several functional areas and/or customers.
- Work on CAPA and Deviations with minimal but some oversight to achieve quality, timely results.
- Bachelor’s degree in Science or Engineering related to biologic industry. Other engineering or science degree considered based on relevant work experience.
- 4+ years of Biotech industry experience in commercial scale manufacturing operations.
- In depth knowledge of current Good Manufacturing Practices and local regulations.
- Knowledge of basic statistical analyses and ability to run and coordinate projects.
- Knowledge of process validation principles and their application in biologics drug substance manufacturing
- Fluent in English and French (Both written and spoken) (Minimum 4/5)
- Suite MS Office (Word/Excel/Powerpoint) and social network supports
- Technical knowledge in protein and viral vectors production paired with technical knowledge in analytical methods.
- Fluent in English & French (spoken and written).
- Employment with an innovative, future-oriented organization.
- Outstanding career and development prospects.
- Exciting company culture which stands for integrity, intensity, involvement and innovation.
At Thermo Fisher Scientific, each one of our 80,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or any other legally protected status.