BBI Solutions is a leading expert in immunoassay development and manufacturing services, and provides an extensive portfolio of products and technologies to the global diagnostic and pharmaceutical markets.
As a business, we are currently progressing through a substantial period of growth, and currently have the exciting opportunity for an Validation Engineer, to join our growing operation. This role will initially be based from our Cardiff site, but will move to our brand new Global Centre of Excellence in Crumlin, by early 2018.
As the Validation Engineer, you will be primarily accountable for the validation and validation maintenance of processes, facilities, equipment, cleaning, CSV and IT projects.
Your key responsibilities will include, but not be limited to the following:
- Plan validation activities to ensure customer and business needs are met in alignment with the overall project plans and objectives. Prepare and issue Validation Master Plans, Summary Reports and other required documentation for a validation exercise. Organize and execute Validation activities in order to provide an effective validation service.
- Provide validation expertise to ensure that all operations are carried out in compliance with regulatory and company requirements. Provide validation support and advice to other areas of the business as required.
- Ensure projects relating to processes, facilities, equipment, cleaning and CSV/IT Validation are validated in line with regulatory and company requirements.
- Provide specialist knowledge on process, facility, equipment, cleaning and automation/IT issues within the site.
- Promote effective working relationships and ensure they are maintained through the validation working party. Support a continuous improvement culture within the business.
- Provide guidance, and direction to staff consistent with ISO13485 and 21 CFR 820.
- Develop work plans, assign tasks, and supervise teams.
- Ensure staff have appropriate knowledge and training on department, site, and processes and procedures
- Address site validation gaps via generation and completion of Validation Master Plans
- Maintain site validation status according to regulatory requirements
- Identify resource requirements and rate limiting steps within the Validation Master Plan.
As the Validation Engineer you will need to be degree qualified with validation experience from within a scientific regulated environment. You will also require the following:
- A good working knowledge of ISO13485 and 21 CFR820
- Experience in direct investigation/troubleshooting of validation problems.
- Experience in Analytical Test Method Validation
- Experience in Equipment Qualification.
- Good statistical knowledge (DOE, capability studies, Gauge R&R, etc.).
- Experience in the areas of qualification, cleaning, analytical methods, lab equipment qualification, computer system validation, and requalification.
- Proficiency in Minitab and Microsoft packages will be a requirement.
You will also be a natural influencer who is energetic in the pursuit of improved processes and innovative in developing solutions.
The salary offering for this role is competitive and makes up part of BBI?s attractive benefits package, which includes:
- 5% contributory pension scheme.
- Life Assurance
- Private health care scheme.
- 28 days? holidays (inclusive of bank holidays) with up to 4 additional days off, including 1 day for your birthday
- Participation in the childcare voucher and cycle to work schemes.
BBI is a fast-paced and agile business, with a track record of growth, and the opportunity to influence and direct the business going forward. We deliver exceptional products and technologies that people rely on to enjoy a better quality of life. We look for our people to be active participants in BBI life, to make work fun as well as challenging.
This job was originally posted as www.jobsite.co.uk/job/959458267