Validation Engineer
Cork
Permanent
Permanent
Validation Engineer - Cork
Client Overview
Our Cork based client is FDA registered and certified to ISO for the manufacture of high-quality PCBAs, subassemblies and complete devices up to and including Class III medical devices. The site’s specialization is manufacturing automation. They provide services for the entire product lifecycle from New Product Introduction (NPI), prototyping and process validation to complex volume manufacturing & test, shipping and repair.
Role Objective
· To formulate and execute validation plans for medical devices including Process, Facilities and CSV.
Duties
Qualification and Experience
Client Overview
Our Cork based client is FDA registered and certified to ISO for the manufacture of high-quality PCBAs, subassemblies and complete devices up to and including Class III medical devices. The site’s specialization is manufacturing automation. They provide services for the entire product lifecycle from New Product Introduction (NPI), prototyping and process validation to complex volume manufacturing & test, shipping and repair.
Role Objective
· To formulate and execute validation plans for medical devices including Process, Facilities and CSV.
Duties
- Own and support validation activities in a Medical Device regulated environment.
- Responsible for all Process Validation Execution.
- Responsible for all Facilities 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.
Qualification and Experience
- QQI Level 7 Degree Preferably in a Science, Electronics, Mechanical or Industrial Engineering
- Minimum of 2 years Quality Assurance / Regulatory affairs experience.
- Experience in working within a Medical Device Manufacturing Environment. FDA 21 CFR Part 820 and ISO .
- Experience in completing Process Validation’s as per FDA and ISO 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.
