Validation Engineer

Cork

‐ Onsite

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Keywords

Training Compliance Support Reviews Quality Assurance Analysis Excel Manufacturing process Qualification Power Point

RESPONSIBILITIES:

Own and support validation activities in a Medical Device regulated environment.
Responsible for all Process Validation Execution
Responsible for all Software Validation Execution
Resolution of Problems encountered during validation.
Ensure Consistency in validation/qualification approach across systems and projects.
Provide guidance and direction in the preparation and execution of validation activities.
Be fully conversant and up to date with GMP requirements for site-wide regulatory body compliance.
Maintain Validation system including conducting Periodic Reviews
Participate in change control processes for manufacturing process and facility modifications.MEASUREMENTS:

ESSENTIAL SKILLS AND QUALIFICATIONS:

3rd Level Degree. (Preferably in a Science, Electronics, Mechanical or Industrial Engineering)

Minimum of 3-4+ years Quality Assurance / Regulatory affairs experience.

Experience in completing Process Validation's as per CDRH Guidance

Experience in using Gamp 4 or Gamp 5 Software V and V Techniques

Sound understanding and utilization of Problem Solving Techniques

Proficient in the use of MS Word, Power-point and Excel

Ability to respond to common inquiries or complaints from internal customers and regulatory agencies.

Ability to write standard operating procedures, training documents, and regulatory responses.

Technically Competent.

Experience in statistical Analysis / DOE and DMAIC methods.

DESIRABLE:

Experience in working within a Medical Device Manufacturing Environment

Six sigma Green or Black Belt Certified

Experience of electronic production processes

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