Job Description
Our client, a healthcare manufacturer based in Dublin, now seeks a Lead Validation Engineer to provide technical support during the NPI process, ensuring that FDA, QSR, & MDD standards are achieved and maintained in respect to device classifications.
Person fit: this role requires an energetic & enthusiastic individual, with proven leadership experience and skills to drive performance and delivery within a fast paced manufacturing environment.
Responsibilities of Lead Validation Engineer:
Provides technical support during the NPI process in ensuring that from a Healthcare/Medical device perspective that all FDA, QSR, & MDD standards are achieved and maintained in respect to device classifications.
Fully competent in the generation and application of quality engineering tools and techniques with key emphasis on validation protocols (DQ, IQ, OQ, & PQ), cGMP, PFMEA's
Experience in developing Validation Plans, Protocols & Checklists.
Experienced background in moulding, automation & equipment validation.
Knowledge of the software qualification guidelines, including GAMP 5.
Experienced background in manufacturing within controlled environments.
Experience in the validation of Cleanrooms & knowledge of ISO14644.
Support the external & internally Quality Management System auditing function (auditor trained).
Exposure & involvement in supporting the CAPA and non-conformance system.
Close liaison and networking with other departments, to provide and drive quality inputs and initiatives into the overall operational activities of the company.
Background in statistical analysis preferable, i.e. Gauge R&R & Cpk.
Mentoring of Quality Validation Engineers & training non Validation individuals in the requirements of Validation.
Requirements for Lead Validation Engineer:
Bachelors Degree in Engineering/Science (Mechanical/Electronics/Chemistry) discipline.
4+ years' experience in a Quality Engineering or Validation role.
Fully competent in Quality Management Standards (ISO 13485 & 21 CFR 820/821)
Fully competent in Regulatory requirements of Validation
Internal Auditor Certificate
Excellent Leadership skills, ability to motivate team members within the organisation.
Excellent organisation, communication, computer, & presentation skills.
Excellent initiative, decision-making and be able to work in a core team environment.
Solution driven with emphasis on Performance and Results.
Please phone Larry on 01-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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Key words; Equipment Validation, Process Validation, Tech Transfers, NPI, CAPA, Auditing, Validation, Cleaning Validation, IQ, OQ, PQ, ISO13485, Compliance, GMP, FDA, Kildare, Wicklow, Dublin, Leinster.