Direct message the job poster from Antaes Consulting
Recruitment Business Partner at Antaes Consulting
To join our Life sciences team in Neuchâtel, we are looking for a candidate managing the validation of manufacturing DP processes through the development, execution, and reporting of engineering and PPQ (Process Performance Qualification) runs.
Your Role :
* Protocol Development: Create and standardize Engineering Runs and PPQ Runs protocols in compliance with applicable regulations, quality standards, and project scopes.
* Execution Support: Collaborate with and guide the Manufacturing team to ensure smooth execution of validation runs, addressing any technical challenges, and ensuring adherence to protocols.
* Documentation & Reporting: Author comprehensive final validation reports, ensuring accuracy, compliance, and integration of all relevant data (e.g., deviations, observations).
* Cross-Function Collaboration: Liaise with Quality Assurance, Process Engineering, and other relevant teams to ensure validation activities align with broader manufacturing goals and timelines.
* Continuous Improvement: Maintain a focus on optimizing validation processes, leveraging technological and procedural best practices to ensure regulatory compliance and efficiency.
Your Profile :
* Minimum 3-5 years of experience FF area for recombinant protein.
* Engineering or university degree in biotechnology
* Language skills: Fluent in English and French
* Experience in utilizing Kneat software for validation documentation and processes
* Proven expertise in process validation within a pharmaceutical or biotechnological manufacturing setting.
* Strong knowledge of Process Validation and Performance Qualification requirements including engineering principles, GMP regulations, and risk management.
* Exceptional technical writing skills, facilitating clear, compliant, and detailed documentation.
* Ability to work collaboratively across teams and communicate effectively in a high-paced environment.
* Problem-solving mindset with attention to detail and commitment to quality.
-----------------------------------------------------------
Founded in 2007, Antaes is a Swiss management and technology consulting company ranked 7th among consulting companies in French-speaking Switzerland. We have over 300 experienced engineers who share our passion.
With offices in Switzerland, Singapore, Hong Kong and France, we support our Swiss and international clients in the following areas.
* Organisation and transformation consulting
* Information Systems Management
By joining our team you will discover :
* A dynamic team in a start-up spirit
* A human accompaniment and a follow-up of your career development
* Challenges to contribute to the development of your network
* A company certified @HappyAtWork and with a committed CSR policy (Ecovadis2023 gold medal)
You too can be part of the Antaes adventure :)
We sincerely appreciate the interest of all applicants in our organization. However, only those selected for further consideration will be contacted.
Where applicable, the masculine form is used for readability purposes and is intended to be inclusive of all genders.
Seniority level
* Seniority level
Associate
Employment type
* Employment type
Full-time
Job function
* Job function
Engineering and Consulting
* Industries
Engineering Services, Pharmaceutical Manufacturing, and Biotechnology Research
Referrals increase your chances of interviewing at Antaes Consulting by 2x
Sign in to set job alerts for “Validation Engineer” roles.
Principal Wafer Fab Process Development Engineer
Process Engineer - RM IT Professional Resources AG
Process Engineer - Manufacturing, cGMP, French
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr