Senior Validation Engineer
Salary: Negotiable DOE + 5% Bonus + Pension + Private Healthcare + Life Insurance + 25 days holidays + 8 bank holidays + Free Parking + Much more!
Location: Site based in Horsham with travel to other sites in the UK & Europe when required
The requirements of the Senior Validation Engineer:
- You must already have 2+ years’ experience working as a Senior Validation Engineer, CSV Engineer, CSV Specialist, Validation Specialist or equivalent role
- Additionally, you will have current experience of CSV (Computer System Validation) in a highly regulated primary or secondary packaging environment ideally in the Pharmaceutical or Medical Devices/Healthcare manufacturing sectors
- Validation/CSV experience in other highly regulated industries such as; Oil & Gas, Nuclear, Food Manufacturing , Automotive, Aerospace will also be considered
- You will be educated to Degree level (or equivalent) in a Engineering or Scientific discipline
- Knowledge of GAMP5 guidelines is a requirement as well as an understanding of the validation life cycle of packaging equipment
- You will be an FBS expert in Equipment Validation and Computer Systems Validation
- Experience in dealing with Local and Regulatory Authorities
- Excellent presentational & motivational skills
- Ability to establish effective working relationships and effective communicator
- Previous experience working with temperature mapping software is an advantage
- You must have a valid UK driving licence and passport to be considered
The role of the Senior Validation Engineer:
As the Senior Validation Engineer, you will be responsible for interacting with several departments to provide validation support to validate computer systems, equipment and equipment systems, along with the critical utilities and facilities required for operations at my client’s sites in both Horsham & Crawley.
- Provide expert subject matter support on Validation & CSV related issues
- Lead and further develop the Engineering Validation departmental capability in conjunction with Director, Engineering & Facilities
- To support validation / qualification activities including equipment, facilities (including temperature mapping), systems, EMS, CSV and temperature-controlled shippers
- Plan and formulate validation aspects of engineering projects including; development and plan Design of Experiments, supporting Proof of Principle work on new products/processes and execution of Engineering studies
- Maintain FCS validation methodology in accordance with applicable Quality/Regulatory requirements and industry best practices
- Perform risk assessment and mitigation supporting the attainment and maintenance of a validated state of compliance for all equipment, processes, materials, and facilities
- Perform technical reviews and interpret data for accuracy of equipment/process performance for completed validations/revalidations
- Author SOPs related to validation/revalidation activities
- Represent Engineering validation in cross-functional meetings/projects as required
- Ensure and/or execute proper calibration and maintenance of test equipment used for validation/revalidation and temperature mapping of equipment, processes and facilities.
- Assist with identification and execution of master validation plan (MVP) as required
- Author, execute, perform, and summarise qualification and validation activities including URS, SIA, QP, DQ, IQ, OQ, PQ, CSV & QSR
- Work closely with engineering to coordinate and execute Factory Acceptance Testing (FAT) & Site Acceptance Testing (SAT) activities and protocols
- Responsible for the completion of change control activities relating to qualification/validation of equipment, facilities, systems, CSV, documentation and databases
- Conduct root cause analysis and deviation resolution for validation exceptions
- My client is the global leader in serving science and supporting their customers to accelerate ground-breaking & lifesaving research across the Pharmaceutical, Medical Devices, Clinical, Biotech & Academia sectors to name just a few
- The Senior Validation Engineer role plays an integral role in the ongoing success of my client’s clinical packaging business which is exclusively focused on serving the packaging and distribution requirements of clinical trials across the world
Apply today by sending your CV to Oliver Gill of Langton Howarth Ltd via email to firstname.lastname@example.org or call Oliver in confidence right now for more information on 0113 243 3499 OR 07792 488 206.
You must have the right to work in the UK to be considered for this role
Langton Howarth also operates a recommend a friend referral scheme. So, if you know someone who could be good for this job, email your nominated candidate’s name and contact details in confidence via email too, and we’ll ensure you receive £100.00 of vouchers from a high street retailer of your choice once we have successfully placed the person referred by you.