Validation Engineer

Validation Engineer – Olive Branch

The Validation Engineer – Olive Branch will play a pivotal role in overseeing and optimizing all aspects of our Olive Branch Validation programs. The position is responsible for process development, maintenance and risk mitigation while ensuring execution of deliverables, communication and fostering a culture of collaboration and continuous improvement.

Key Responsibilities:

• Responsibility for targeted planning, optimization and implementation of qualifications and (re)validations of production facilities and manufacturing processes in accordance with the management systems (EN ISO 13485, 21 CFR-Part 820), including protocol and process generation taking into account applicable quality standards.
• Perform gap assessments with respect to Site Master Validation Plan.
• Carry out and implement assigned Tasks, Projects, (re)validations, risk analysis per ISO 14971, compliance monitoring, capability studies and prepare statistical evaluations.
• Author validation plans, IQ, OQ, PQ protocols and reports along with updating current state company process documentation to ensure compliance with current internal and external regulations.
• Evaluation of change requests, non-conformances, deviations and CAPA with regard to qualification and validation requirements.
• Communicate, Coordinate and Manage Change Control with our Customers as well as implementation of changes into production.
• Maximize uptime for Operations while ensuring spare parts and redundancy measures are in place.
• Manage and Optimize facility Calibration initiatives.
• Support and execute design controls, process controls to hazardous situations, complaints, non-conformances on cross functional teams.
• Consult executive leadership on risk management process defining a robust and sustainable approach to FMEA including sustainable approaches to product lifecycle risk management.
• Develop and Deploy training for the remediation program for performing gap analysis activities for IQ, OQ, PQ.
• Subject matter expert for software applications and qualification and validation topics including but not limited to root cause analysis, remediation, impact assessments for new processes, documentation and audits inside the Quality Management System.

Requirements:

• Bachelor's degree in the field of mechanical engineering, process engineering or a comparable technical education.
• Proven track record and proficiency in Design and Process Controls, Process Qualification and Validation requirements.
• Knowledge of industry regulations and manufacturing standards and guidelines for medical devices, including DIN ISO 13485, 21 CFR Part 820, GMP Annex 15 and DIN EN ISO 14971.
• Knowledge in validation of computerized systems and software according to 21 CFR Part 11, ISO13485, GMP Annex 11, ISO 14971, EUMDR and GAMP 5.
• Strong knowledge of MS Excel, Macro creation and statistical methods (e.g. Minitab)
• Strong problem-solving and Analytical skills.
• Excellent communication, teamwork, interpersonal abilities and solution-oriented.

Note: This position does not offer a relocation package or sponsorship. Candidates must be located in Olive Branch, Mississippi or be willing to relocate at their own expense.