-
Validation Engineer
2 days ago
Newton Colmore Cambridge, Cambridgeshire, United KingdomValidation Engineer - Medical Devices · A growing medical devices company based in Cambridgeshire are in the process of expansion and are actively looking for an experienced Validation Engineer to join the team. · The role as Validation Engineer will give you the opportunity to w ...
-
Validation Engineer
1 week ago
Joveo Cambridge, United Kingdom Full timeValidation Qualification & Processes &Risk Assessments Job Title: Validation Engineer · Location: Cambridge · Job type: 24-Months Fixed Term Contract · At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly ...
-
Validation Engineer
4 days ago
AES Cambridge, Cambridgeshire, United KingdomCambridgeshire (Hybrid) · Salary: £65,000 to £75,000 (DOE) + Excellent Benefits / Prospects (including Relocation Assistance) · The Company: Our Client, an innovative dynamic passionate Company that manufactures minimal invasive next-generation robotic-assisted medical devices th ...
-
Validation Engineer
1 week ago
Mundipharma Cambridge, United Kingdom Full timeDescription · : Primary Location: · GB Cambridge Job Posting Date: · Job Type: · Fixed Term Contract (Fixed Term) ...
-
Test & Validation Engineer
1 week ago
RHL Peterborough, United KingdomHave you got experience with off-highway equipment? We are looking for a Test & Validation Engineer to join a global manufacturing company based in Peterborough, on a 12-month contract. · Experience is key in this role, working closely with the technicians you will be involved in ...
-
Test & Validation Engineer
1 week ago
Jonathan Lee Recruitment Peterborough, United Kingdom**Test & Validation Engineer** · **Up to £36/hr - Inside IR35** · **Peterborough - with flex working** · **12 month initial contract - Long term** · A Test and Development Engineer opportunity has become available for one of the world's leading manufacturers of off-highway machin ...
-
Design Validation Engineer
2 days ago
Hernshead Recruitment Ltd Cambridge, United Kingdom Contract, Full timeAbout The Role: · We are looking for a Design Validation Engineer to join our clients Test & Validation team. · Responsibilities: · * Test Planning and Execution: · * Develop comprehensive test plans and execute Design Validation testing to verify the performance and functionalit ...
-
Design Validation Engineer
1 week ago
Energy Jobline CVL Cambridge, Cambridgeshire, United KingdomLocation: Cambridge (CB24) · Duration: Permanent Hours: 9am until 5pm (Monday to Friday) Salary: Up to £55,000Job Reference: 35053Polytec are looking for a Design Validation Engineer for our client based just north of Cambridge. Responsibilities: * Develop comprehensive test plan ...
-
RF Validation Engineer
1 week ago
IC Resources Cambridge, United Kingdom Full timeIC Resources is working with a Cambridge based client who is looking for an RF Validation engineer to join them on a contracting basis. · The RoleOnsite in Cambridge · Outside IR35 · 3-6 month contract · RequirementsRF Testing expertise · Experience in the communications indust ...
-
Staff Validation Engineer
5 days ago
AES Cambridge, Cambridgeshire, United KingdomCambridgeshire (Hybrid) · Salary: £65,000 to £75,000 (DOE) + Excellent Benefits / Prospects (including Relocation Assistance) · The Company: Our Client, an innovative dynamic passionate Company that manufactures minimal invasive next-generation robotic-assisted medical devices th ...
-
RF Validation Engineer
1 week ago
IC Resources Cambridge, United Kingdom FreelanceIC Resources is working with a Cambridge based client who is looking for an RF Validation engineer to join them on a contracting basis. The RoleOnsite in CambridgeOutside IR353-6 month contractRequirementsRF Testing expertiseExperience in the communications industryRF integration ...
-
Senior Verification/Validation Engineer
1 day ago
Ecm Selection Cambridge, Cambridgeshire, United KingdomAt ECM, we're scientists and engineers offering a personal service to help our peers find jobs - register with us , and let us do the hard work for you. · Verification & Validation Engineer, Scientific Instrumentation · Senior engineering role involved in test methods and strat ...
-
Senior Verification/Validation Engineer
3 days ago
Ecm Selection Cambridge, Cambridgeshire, United KingdomThe company's core technology is around rapid molecular biological applications through point-of-care diagnostics. Their ability to impact the detection of infectious diseases enables communities to stay ahead and keep populations safe. Central to their projects is a key role in ...
-
IC Verification and Validation Engineer
4 days ago
ECM Selection Cambridge, United Kingdom Permanent, Full timeGrowing IC design team seeks experienced engineer · This smart and supportive silicon team are looking for someone to help with the verification and validation of their mixed signal IC designs. You will be creating and updating a test suite that covers the whole IC development pr ...
-
Senior Verification and Validation Engineer
1 week ago
ARM Cambridge, Cambridgeshire, United KingdomThis position provides an exceptional opportunity for a highly motivated and experienced verification engineer to join the engaging, hardworking, and creative System IP team. · The latest and most advanced hardware design and verification methodologies are employed to create the ...
-
Lead Verification and Validation Engineer
1 week ago
Multimatic Inc. Cambridge, United KingdomLead Verification and Validation Engineer · Location: Multimatic Electronic Systems UK, Cambridge, Cambridgeshire, United Kingdom · Posted: November 29th, 2023 · Lead Verification and Validation Engineer · Multimatic - Solving our customers' problems through the know-how we emb ...
-
European Recruitment Cambridge, Cambridgeshire, United KingdomFormal Verification Engineer We are working with the world's largest CPU development company who are looking to add an experienced Formal Verification Engineer for their systems IP team in Cambridge. This is a permanent role that can be worked on-site in Cambridge, Manchester or ...
-
IC Verification and Validation Engineer
4 days ago
ECM Selection Cambridge, United Kingdom Full timeGrowing IC design team seeks experienced engineerThis smart and supportive silicon team are looking for someone to help with the verification and validation of their mixed signal IC designs. You will be creating and updating a test suite that covers the whole IC development proce ...
-
Senior Verification and Validation Engineer
1 week ago
European Recruitment Cambridge, Cambridgeshire, United KingdomJob Description Verification Engineering opportunity with a globally prestigious semiconductor company at their HQ in Cambridge, at senior and staff levels of seniority. · Owning a CPU project and developing it through all stages of the verification process · Production of veri ...
-
Senior Validation and Verification Engineer
1 week ago
European Recruitment Cambridgeshire, United KingdomCPU Verification Engineer - Cutting Edge - Global Leader - Reputable Semiconductor Company · Would you like to work at one of the most cutting edge leading semiconductor companies globally? · I'm currently on the lookout for multiple Verification Engineers to work within the CPU ...
Validation Engineer - Cambridge, Cambridgeshire, United Kingdom - Mundipharma International
Description
Job Title: Validation Engineer
Location: Cambridge
Job type: 24-Months Fixed Term Contract
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.
The Validation Engineer needs to provide Validation leadership, Specialist Knowledge and 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.
Role and responsibilities
Leads assigned validation projects ensuring compliant and timely performance, in line with GMP requirements, industry standards (e.g. GAMP5), company procedures and business requirements.
Define in collaboration with key stakeholders of the validation strategy following a risk-based approach as per ICH Q9 and ensuring regulatory and GMP requirements are met.
Prepare validations protocols in line with defined and approved validation strategy and company templates.
Management of nonconformances and resolution of issues with key stakeholders and/or the Qualified Person as appropriate.
Input into the User Requirements Specification (URS) and co-oversight of Factory and Site Acceptance Testing (FAT/SAT).
Coordination of the execution of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) as defined in the respective validation protocols.
Supporting change control activities, including performing impact assessments of changes.
Performing or supporting risk assessments (e.g. FMEA) and the identification of risk control measures.
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.
What you'll bring
Scientific degree in Pharmacy, Chemistry, Biology, Engineering or similar, or aligned working experience.
Formal training in pharmaceutical validation (e.g. GAMP5 or IPSE)
Practical experience in QA and/or Validation roles within the Pharmaceutical and/or Medical Devices Industry.
Good knowledge and application of GMP and Pharmaceutical regulatory requirements.
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, HACCP.
Extensive knowledge and experience of various manufacturing processes and equipment for various dosage forms.
Solid understanding of computerized 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 report writing skills and ability to communicate and interact at all levels of the business and externally.
What we offer in return
flexible benefits package
opportunities for learning & development
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, as we focus on making a positive difference for our customers and their patients.
About Mundipharma
Mundipharma is a global healthcare company with a presence 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 and Consumer Healthcare as well as other severe debilitating disease areas. Our guiding principles, centered around Integrity and Patients-Centricity, are at the heart of everything we do.
Join our talent pool
If you're not sure this role is right for you but you're keen to hear about future opportunities at Mundipharma, join our talent community and be the first to hear about new roles.
Mundipharma is a global healthcare company with a presence 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 and Consumer Healthcare as well as other severe and debilitating disease areas. Our guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything we do.
For more information about Mundipharma's guiding principles and commitment to diversity and inclusion visit:
#J-18808-Ljbffr