Our client is looking to hire an experienced Validation Lead to join their biomanufacturing site in Lendava, as Validation Lead you will be responsible for developing, implementing and managing the site process validation, primary packaging validation, cleaning validation and revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities’ expectations.
Your Key Responsibilities
Your responsibilities include, but not limited to:
- Leading the MS&T validation team of Validation experts and senior experts.
- Defining and implementing the validation strategy for production and cleaning process, for both for initial validation and Ongoing Process or Cleaning verification (OPC, OCV) as well as advocacy to the relevant authorities.
- Overall responsibility for establishing, prioritizing, implementing and tracking the validation master plans, protocols and reports for process and cleaning validation, and related studies, like mixing, hold times, reuse, etc.).
- Ensuring that all production and purification processes and other supporting processes are validated and that a validation status is maintained on site. This includes ensuring that all validation activities are carried out on site and are compliant with applicable Sandoz requirements, current GMP guidelines and regulatory requirements.
- Addressing deviations and changes related to Process and Cleaning, including oversight of validation preparation, execution and reporting resulting from technical changes.
- Preparation of more complex validation protocols, participation, review and approval of the validation documentation.
- In concert with the Tech Transfer Lead, work in close collaboration with the sending site (development organization or production facility) for new product launches and site to site technical transfers.
- In collaboration with Engineering, IT, QC, AS&T units, identify and collaborate with contact persons for equipment/infrastructure qualification, systems qualification, and analytical methods validation.
- Participation in providing data obtained during validation for use in preparation of registration dossiers.
- Representing the site in global validation teams.
What You Will Bring To The Role
- Minimum 12 years of relevant experience in biomanufacturing, in MS&T or quality, with a focus on validation of large scale mammalian drug substance manufacturing.
- Proven expertise in leading teams of experts.
- Proven expertise with Process and Cleaning validation in large scale mammalian or microbial Drug substance production facilities.
- MSc. in Pharmacy, Pharmaceutical Technology, Biochemistry, Chemical Engineering, or related scientific discipline. PhD or equivalent is preferred.
- Strong understanding of regulatory requirements, process validation, continued process verification, and cGMP.
- Excellent communication and presentation skills.
- Strong English communication skills required; familiarity with the local language is a plus.
You’ll Receive
Employment at the most reputable employer in Slovenia offers Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being (WellBeat), Unlimited learning and development opportunities.
Our client offers a permanent contract with a 6-month probation period. You are kindly invited to submit your application in English language, including your CV.
Why our client?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Our client, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of our client and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!