Production Process Validation Engineer
Our client, an engineering company in Germany are currently looking to recruit a Production Process Validation Engineer for their site, for an hourly contracting basis.
The successful candidate will
- Evaluate and calibrate the equipment and procedures used in development and production of a variety of products.
- Establish validation standards, develop testing protocols, prepare equipment, conduct tests, document test results, maintain records for later analysis and report findings.
- Make adjustments to equipment or processes that require improvement, decide if equipment needs to be repaired or entirely replaced.
- Must coordinate with other personnel or departments who will be affected by testing.
- Other duties include preventative maintenance, maintenance of testing equipment and overseeing the inventory of validation supplies.
- Address corrections and corrective actions concerning production process validation.
- Contribute to closing NCs.
- Contribute to closing CAPAs.
- Implement sustainable, best practice protocols.
- Bachelor's degree in Engineering is the minimum qualification for entry level validation technician positions. Completion of a master's degree program can be of benefit.
- Minimum of 2 years' experience within the Medical Device industry
- Knowledge of FDA 21, CFR 820 and ISO 13485
- Additional knowledge and skills may include computer programming languages, or a biological or medical background or laboratory experience.
- Familiar with authoring protocols and reports; specific to the validation of test methods
- Understands statistics and how they pertain to test method validation
- Experience in performing test method validation protocols
- Experience working with suppliers for the development of inspection methods
- Understanding of correlation studies between two similar inspection method / techniques
- Experience / Understanding of various inspection techniques and inspection tools required
- Direct experience performing test method validation(s)
- Must understand technical oral/written English
- Project and time management skills
- Excellent technical writing skills
For further information on this Production Process Validation Engineer role in Germany please contact Anna McGowan on 091730022 / firstname.lastname@example.org
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