Houston Metro Area, TX
The Validation Engineer will lead, execute, document & manage the validation activities necessary to support the introduction or revision of production equipment.
The Validation Engineer will be responsible for identifying deficiencies or gaps in the validation lifecycle, developing remediation plans to remediate the process and equipment validation, and ensuring that all remediation activities are completed as scheduled in the remediation schedule.
The Validation Engineer will review or author routine re-validation protocols and reports that meet all internal & external requirements for validation.
The Validation Engineer will also to support the Site process validation, primary packaging validation, cleaning validation and revalidation strategies to meet cGMP requirements on time, on budget and quality to ensure that programs are compliant with inspection agencies requirements and related SOPs.
Validation Engineers will understand and apply the concepts of Continuous Monitoring to ensure that processes that have been transferred into production are being monitoring & controlled appropriately to maintain the equipment in a validated state.
The Validation Engineer will also be responsible to provide guidance in the translation of critical process parameters and the process control strategy into a focused validation plan for process and equipment validations.
Lastly, the Validation Engineer will be expected to continuously improve internal systems/processes to ensure limited resources are utilized efficiently. Promote cooperation and teamwork with all departments through open, candid communication and timely coordination.