Job Description

OMI-P2-11
Validation Engineer
Location: Cambridge
Department: Validation
Job type: FTC
Join us and make a difference when it matters most!
At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees.
Role and Responsibilities
Executes validation projects, ensuring these are completed in line with GMP requirements, industry standards, company procedures and business requirements, collaborating with key stakeholders for the design, preparation, completion and final reporting.Leads assigned validation projects ensuring compliant and timely performance, in line with GMP requirements, industry standards (e.g. GAMP5, ISPE), company procedures and business requirements, including the following activities Collaborate with key stakeholders on the definition of validation scope and strategy - Apply a risk-based approach to determine validation deliverables as per ICH Q9, to ensure regulatory and GMP requirements are met while working to project timelines Prepare validation documentation in line with defined and approved validation strategy and company templates, coordinating review and approval by the required stakeholders and issuance through the company's document management system Manage nonconformances and resolve issues by working with key stakeholders, including vendors, Engineering, Production and/or liaise with Quality Assurance and/or Qualified Person as appropriate Input into the User Requirements Specification (URS) and co-oversight of Factory and Site Acceptance Testing (FAT/SAT) as required Coordinate the execution of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) as defined in respective validation protocols, in collaboration with Production and Quality Control departments, and IT Write up of validation reports for each stage of the validation cycle, coordinating the review and approval by the required stakeholders and issuance through the company's document management system Ensure documentation is completed and compliant with data integrity requirements Liaise with Quality Assurance to provide the necessary validation documentation to support batch certification by the Qualified Person. Supports the business in managing the risk to quality by supporting change control activities, including performing impact assessments of changes, as required - performing or supporting risk assessments (e.g. FMEA) and the identification of risk control measures as appropriate - leading or contributing to the definition of control strategy for new equipment, software, and/or processes, in close collaboration with Production and Quality Assurance Contributes to the company inspection readiness and compliance programs by completing on-time all assigned Quality System commitments (including Change Control actions, CAPA, training, document periodic reviews) - supporting internal and external audits as validation SME and validation project owner Ensures continuous professional development in order to stay up to date with current technology and validation regulatory standards and expectations

What you'll bringFormal training in pharmaceutical validation (e.g. GAMP5 or ISPE) Practical experience in QA and/or Validation roles within the Pharmaceutical and/or Medical Devices Industry Practical experience in QA and/or Validation roles within the Pharmaceutical and/or Medical Devices Industry Excellent knowledge and application of GMP and Pharmaceutical regulatory requirements Excellent knowledge of good documentation practices Good knowledge and understanding of data integrity requirements and elements Breadth and depth of knowledge and application of pharmaceutical validation requirements, including EudraLex Vol. 4 Annex 5, Annex 11, and Annex 15, GAMP5 Good knowledge and experience of Quality Risk Management, including in risk assessment tools, e.g. FMEA, Ishikawa, 5Whys Extensive knowledge and experience of various manufacturing processes and equipment for various dosage forms Good understanding of computerised systems validation requirements Appropriate understanding of health & safety requirements and the impact to validation Experience in supporting external audits by customers and competent authorities as subject matter expert Excellent technical writing skills and ability to communicate and interact at all levels of the business and externally

What we offer in returnFlexible benefits package Opportunities for learning & development through our varied programme Collaborative, inclusive work environment

Diversity and inclusion
Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We believe this isn't just the right thing, but also the smart thing to do. We are on a journey and will seek to move forward together through education and awareness to build a culture that welcomes and celebrates diversity and uniqueness. We will create a workplace environment where everyone can, every day, bring their authentic selves and is treated with dignity and respect.
About Mundipharma
Mundipharma is a global healthcare company focussing on customers across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.
Mundipharma is dedicated to bringing innovative treatments to patients in the areas of pain management, infectious disease as well as other severe and debilitating disease areas. Their guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything they do. For more information visit www.mundipharma.com.
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Additional :
Primary Location:
GB Cambridge
Job Posting Date:
2025-05-08
Job Type:
Fixed Term Contract (Fixed Term)