Senior Validation Engineer - Netherlands
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- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
- The Center of Excellence Biotech Technical Operations gives technical support, process support, troubleshooting and continuous improvement to the local Biotech upstream and downstream Integrated Process Teams (manufacturing) and is involved by process fit in introduction of new biologics products in the manufacturing facilities.
- Team members within Biotech Technical Operations collaborate with other technical groups across a global network.
- The team consists of approximately 50 members, with expertise in microbiology, cell culture, purification and/ or engineering.
As part of the Cleaning/Sterilization Validation team, and reporting to the Cleaning & Sterilization Validation lead, the Senior Validation Engineer independently completes activities related to the items below:
- Ensuring all aspects of Cleaning and Sterilization Validation adhere to company's global policies, procedures and guidelines and external regulatory requirements;
- Generating and executing validation protocols to demonstrate compliance to a standard suitable for review by internal and external auditors;
- Authoring, Review and/or Oversight of cleaning and sterilization validation-related procedures, protocols and technical reports required;
- Providing product impact and root cause assessments on cleaning and sterilization related events and anticipated changes;
- Driving improvements in cleaning and sterilization validation.
Areas of Responsibility
- Primary source for cleaning and sterilization validation systems knowledge, including experience with Validation of steam in place (SIP) sterilization, autoclave sterilization, dry heat sterilization and sterilizing filtration. Responsible for validation-related activities, such as:
- Ensure Validation Plans and strategies are in alignment with company's global policies, procedures and guidelines and external regulatory requirements, and European and International standards;
- Responsible for Sub-System Ownership for CH35, and provide Support to other Sub-System Owners which overlap in the implementation of changes and system improvements;
- In partnership with Quality, Sub-System Owners and Technical Operations, develop sterilization re-validation programs, as appropriate;
- Accountable for compliance of the site sterilization validation program via documentation completion, risk assessments, proactive identification of risks /issues, review of protocols and reports, closure of preventative and corrective actions, and participation in audits and inspections;
- Participate on investigation teams in the event of adverse sterilization validation trends/failures to identify root cause and corrective/preventative actions. Expected to bring validation expertise and strong analytical and systematic problem solving skills;
- Ensure alignment in sterilization validation approaches across the company Network, taking an end-to-end viewpoint to ensure successful and reliable product supply;
- In collaboration with the Product Teams, development groups (e.g. BMSC) and Biotech Technical Operations (BTO) Process Leads, support sterilization validation needs to meet regulatory expectations and supply timelines;
- Facilitates in problem solving & risk assessment (FMEA) projects/meetings;
- Develop meaningful validation metrics/trending to enable continued drive for reliability and efficiency.
- Academic degree/PHD in life sciences (Biotechnology or related) or comparable level through experience;
- At least 5 years of validation/ manufacturing experience, in a GMP setting. Preference for experience in biologics manufacturing (cell culture, purification);
- Proven strong scientific, project & people management skills;
- Strong communicator and ability to build bridges between groups and organizations. Ability to create a team spirit;
- Knowledge of GMP guidelines and global validation expectations;
- Willingness to certify for or possessing Six Sigma Green Belt or Black belt degree;
- Passion for Lean and Continuous Improvement;
- Customer focused, process oriented and data driven;
- Good command of writing and speaking in Dutch and English;
- Percentage in service at least 90%.
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