Validation Specialist I

This is a contract role for one year

As a Junior Validation Specialist at our pharmaceutical facility, you will be integral in ensuring the compliance and efficiency of our compression and coating processes. Your role will focus on generating System Development Life Cycle (SDLC) documentation, performing validations, and qualifying systems crucial for pharmaceutical product development and manufacturing. This position involves maintaining the integrity of data and product quality, with a specific emphasis on troubleshooting, statistical analysis, and system decommissioning in accordance with regulatory requirements.

Responsibilities:

• Conduct validation activities related to compression and coating processes, ensuring systems operate within regulatory guidelines to maintain data integrity and product quality.
• Develop and manage project plans for system validations, including troubleshooting and mean comparison analyses using statistical tools like Minitab.
• Generate and maintain documentation throughout the system lifecycle, particularly focusing on the validation phases, using control charts and other statistical methods to ensure process control.
• Participate in investigations and troubleshooting of process deviations; identify root causes and implement corrective/preventive actions.
• Assist in the decommissioning of outdated systems and equipment, ensuring compliance with environmental and safety standards.
• Coordinate with various teams to execute projects, including system installation, validation, and maintenance, ensuring minimal environmental impact during decommissioning.
• Handle validation deviations, participating in deviation investigations to define corrective and/or preventative actions (CAPA).

Qualifications:

• BS/BA degree in Science, Engineering, or a related field.
• Minimum of 1 year of relevant experience in a pharmaceutical validation role, with direct experience in compression and coating processes.
• Proficiency in statistical analysis tools such as Minitab for control chart analysis and basic statistical comparisons.
• Excellent understanding of FDA regulations, GMP, and environmental regulations relevant to pharmaceutical manufacturing.
• Strong organizational skills and attention to detail.

Preferred Qualifications:

• Experience with decommissioning of pharmaceutical systems, ensuring compliance with environmental and safety standards.
• Knowledge in conducting environmental impact assessments and familiarity with waste management practices in the context of pharmaceutical decommissioning.

This is a contract position offering a unique opportunity to contribute to the lifecycle management of key pharmaceutical manufacturing systems and equipment, ensuring their operation, maintenance, and decommissioning are carried out safely and compliantly.