- To follow the technology transfer phases from the initial project kick-off to the commercial readiness, acting as a point of reference for Quality and Validation technical aspects.
- To work closely with technical and quality teams to develop a robust validation strategy.
- To author Process and Cleaning Validation protocols and reports for registration and validation batches, in accordance with GMP and corporate standards
- To provide Qualitative and Technical recommendations to permit site operation within regulatory requirements.
- To statistically process data through computer applications (Excel/Minitab)
- To oversee manufacturing activities related to registration and validation batches
- To ensure that new product introduction and all process changes are adequately evaluated and handled through change control management
- To support in preparation and participation to Clients' and Regulatory audits with regards to validation activities.
- Science based degree e.g. BSc or MSc
- Previous professional experience in process and cleaning validation in the pharmaceutical industries, preferably sterile manufacturing.
- Proficient knowledge of process validation, cleaning validation and continuous process improvement.
- Knowledge of mainstream statistical software analysis programs such as MiniTab.
- Solid understanding of EU/US GMP regulations and guidelines for UK as per the 'Orange Guide.'
- Technical writing skills - Deviations, reports, investigations, SOPs.
- Excellent interpersonal skills, communication, and organizational skills
- Ability to multi-task, meeting tight deadlines.
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QA Validation Engineer - Swindon, United Kingdom - Thermo Fisher
Description
Position Summary:
We have an opening within the Proactive Quality department at our Swindon site for an experience Validation Engineer.
As a qualified individual you will lead site wide process and cleaning validation activities and will be responsible for planning and implementing process validation studies in support of PPQ batches and commercial process optimisations. This role will be primarily responsible for authoring process and cleaning validation protocols, overseeing study execution, analysing the findings, and creating written reports summarising the findings. This role will require cross-functional work with QA, operations, quality control and process engineering to ensure validation studies are performed appropriately according to site policies and regulations.
Responsibilities:
EH&S:
Understand and ensure implementation of emergency procedures and safe systems of work. Ensure compliance with environment, health and safety rules, signage and instructions at all times. Ensure timely reporting and investigation of all accidents, near misses and breaches of rules.
Minimum Requirements/Qualifications:
Benefits we offer:
In addition to a competitive base salary, you'll be eligible for company annual bonus, contributory pension plan, private medical insurance, life assurance, annual reviews, Employee Assistance Programme, 25 days holiday + Bank Holidays, free on-site car parking as well as other optional flexible benefits such as holiday purchase plan that you can tailor to suit you
About us
When you're part of Thermo Fisher Scientific, you'll do challenging work with a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
