Validation Engineer II

Validation Engineer II

Validation/qualification of manufacturing equipment, facilities, utilities and computerized systems associated with the manufacture of pharmaceutical or medical devices to assure compliance with cGMP's, FDA's and BLP's guidelines. Job assignments are to be completed without a considerable amount of supervision or coaching. Assume the responsibility for the GMP and Environmental Health and Safety procedure awareness, and compliance within the respective area.

Key Activities/Responsibilities:

• Develop sound scientific rationale/strategy for validation of new or modified cGMP equipment and processes.
• Design, implement and execute protocols to validate manufacturing equipment, facilities, utilities in a manufacturing environment following the latest cGMP regulations.
• Assess and perform process/equipment/systems requalification's to confirm and provide evidence that such systems remain in a validated state.
• Evaluate test data and write final reports to summarize testing performed. Gather all pertinent documentation required for completing the validation activity.
• Perform project management duties for limited number of CIP/compliance related projects.
• Communicate the requirements, scheduling, results and impact of the performance of the above projects to ensure efficient and successful turnover of validated equipment or systems to the customer in support of the manufacture of sterile pharmaceutical product.
• Ability to run projects and coordinate personnel.
• All other duties as assigned.

Qualifications/Training:

• Experience in one or all of the following types of validation desired: Utilities, facilities, manufacturing process equipment (compounding, filling, and packaging), sterilization processes including moist heat, dry heat, gamma, and ethylene oxide.
• Computerized systems/SQA experience is a plus.
• Strong Project Management, organizational, analytical, computer, writing and communication skills.
• Knowledge of aseptic processing highly desired. Excellent logical/mechanical aptitude desired.
• Knowledge of cGMP regulations and latest validation guidelines.
• Able to handle multiple priorities in a fast-paced environment.
• Able to work extended/odd hours around manufacturing schedule required.
• Must be able to read, write, and speak English and possess basic math skills.