Validation Engineer

->Provide validation support on process, equipment, software, and facilities changes while ensuring the validation and qualification activities are consistent with regulations and Company’s validation policies and procedures.

->Generate, review, and approve documentation supporting validation activities (plans, protocols, reports, technical documents, pFMEAs).

->Execute functions needed to support change control activities and document management requirements by collaborating with business partners and peers to define validation and change control activity requirements.

->Support validation lifecycle by developing and maintaining validation change notices, including requirements and process status.

->Participate in process mapping/process analysis and in the preparation of risk assessments to support investigations and implementation of process and equipment changes.

->Participate in the creation and evaluation of statistical sampling plans and rationale to support product specifications and validation protocols. Provide recommendations for amendments to sampling plans to ensure appropriate product control plans are in place.