Validation Engineer jobs in Pensacola, FL

SUMMARY:

The Validations Engineer I provides technical support for product and process development and technical troubleshooting, from execution of equipment qualifications, process and packaging validations, and cleaning validations.

RESPONSIBILITIES:

• Execute tasks per protocols and write reports in accordance with cGMP’s for validation and qualification.
• Provide support for product and process development, including process scale-up to validation approval per stage gate process.
• Perform sample and sample preparation in support of cleaning, process, and packaging validation protocols. Must be able to analyze and review raw data and interpret results.
• Partners with Operations and Project Manager to track equipment and set timelines for project requirements. Support revalidations activities and provide updates and project times to the Validations team.
• Manages and monitors ongoing product validation activities including cleaning and manufacturing processes. Utilize a risk-based approach to establish and maintain the validation program specific to each product.
• Responsible for maintaining and reporting activities via periodic reports and project allocation.
• Support technical investigations with operations and quality teams.
• Other tasks as assigned or requested.

QUALIFICATIONS AND REQUIREMENTS:

• Bachelor’s degree in chemical, mechanical, or industrial engineering; Master’s degree preferred
• 1 years of experience in manufacturing environment
• 3 years’ experience in manufacturing environment including pharmaceutical process design, scale-up, and equipment qualifications preferred. cGMP and statistical process performance a plus.
• Proficient in Microsoft Office Suite including Word, Excel, and Outlook.
• Experience with Minitab Statistical Software preferred.
• Must be able to identify and translate priorities into clear and actionable goals. Effective time management is required for proper execution of plans, to anticipate problems, and develop contingencies.
• Able to establish strong relationships and able to effectively communicate, written and verbally, with other departments to achieve shared objectives.