ENGINEER, VALIDATION

Job Title

Engineer, Validation

Position Requirements

Will work within the QA Shared Services Validation Team, responsible for validation related activities, including, but not limited to the following:

Having knowledge of and ability to provide Interpretation and Guidance on Regulations, Corporate, Divisional and Site Local procedures as they relate to validation activities.

Participating within Corporate Validation Team to develop and revise Validation Procedures.

Being Subject Matter Expert (SME) for more than 1 validation specialty for development.

Review and Understand Quality & Change management agreements.

Collect the Change requests from vendor and understand the status and Priorities.

Work with CFT team in collecting inputs related to Specific SICR's

Collaborate with vendor for getting the PPAP, MSA, GR&R & SICR in compliance.

Support CFT team with action related to Supplier change review board [CRB] and assist in decision making for ECN / NON-ECN type of changes.

Support in collecting additional information on the SICR request if needed

Participate in Change review board and assist in decision making process.

Conduct virtual audit and evaluation for Validation protocols & reports (IQ/OQ/PQ), Procedure changes, if process or material change is approved by CRB team.

Establish and lead meetings with CFT and Vendor periodically for technical meetings.

Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.

Must be willing to work as part of a multi-site team, be able to travel as part of the job

Working knowledge/experience of Risk Based Techniques i.e. FMEAs, FTAs etc.

Have a good understanding of statistical techniques, in particular statistical sampling plans, Process Capability, Gauge R&Rs.

Lean Six Sigma training is a distinct advantage.

Excellent knowledge of all validation elements (all validation documents and specialties)

Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).

Thorough knowledge and understanding of International Medical Device Regulations

Experience in interacting with regulatory agencies (FDA, TÜV, etc.)

Highly developed problem solving and strong analytical skills.

Full time