- Leads assigned validation projects while ensuring compliance with GMP requirements and industry standards.
- Defines validation strategies in collaboration with stakeholders following a risk-based approach and ensuring regulatory and GMP compliance.
- Prepares validation protocols and manages nonconformances and issue resolution.
- Coordinates the execution of qualification processes and supports change control activities.
- Conducts risk assessments and completes Quality System commitments on time.
- Supports internal and external audits as a validation SME.
- Scientific degree in Pharmacy, Chemistry, Biology, Engineering, or related fields.
- Formal training in pharmaceutical validation and practical experience in QA/validation roles.
- Good knowledge of GMP and Pharmaceutical regulatory requirements.
- Extensive knowledge of pharmaceutical validation requirements and risk management.
- Experience in various manufacturing processes, equipment, and computerized systems validation.
- Understanding of Health & Safety requirements and experience in supporting external audits.
- Strong technical report writing and communication skills.
- Flexible benefits package
- Opportunities for learning & development
- Collaborative, inclusive work environment
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IC Resources Bristol, United Kingdom Full timeAn opportunity has become available for a Senior Validation Engineer to join a revolutionary AI startup based in Bristol. · As a Senior Validation Engineer you will have a number of responsibilities that include;Post silicon validation and characterisation · Create and execute co ...
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IC Resources Bristol, United Kingdom Full timeAn opportunity has become available for a Senior Validation Engineer to join a revolutionary AI startup based in Bristol. As a Senior Validation Engineer you will have a number of responsibilities that include;Post silicon validation and characterisationCreate and execute complex ...
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Validation Engineer - Hillesley, United Kingdom - Mundipharma
Description
At Mundipharma, we take pride in our work to introduce innovative treatments to patients. We continuously push ourselves to deliver more for patients, healthcare professionals, partners, and employees.
The Validation Engineer is responsible for providing Validation leadership, specialized knowledge, and executing validation projects in accordance with GMP requirements, industry standards, company procedures, and business needs. This role involves collaborating with key stakeholders for the design, preparation, completion, and reporting of projects.
What we offer in return
Diversity and inclusion
Creating an inclusive environment where individuals can thrive and reach their full potential is a top priority. We believe this is not only the right thing to do but also the smart thing as we strive to make a positive impact for our customers and their patients.
About Mundipharma
Mundipharma is a global healthcare company with a presence in Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East. Our focus is on bringing innovative treatments to patients in Pain Management, Infectious Disease, Consumer Healthcare, and other severe illness areas, guided by Integrity and Patients-Centricity.
Join our talent pool
If you are interested in future opportunities at Mundipharma, join our talent community to stay updated on new roles.
