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Job Description:

• Manage GMP protocols and reports for validation projects

• Ensure that work is performed in accordance with applicable regulations, industry guidelines and practices, approved procedures and cGMP.

• Author and execute protocols as well as, writing comprehensive final reports including thorough resolution of protocol discrepancies.

• Responsible for authoring and executing facility qualification protocols (HVAC IQ, OQ, PQ)

• Responsible for the validation (IQ, OQ, PQ) of various types of equipment systems: validation or re-qualification of filling and packaging lines, parts washer, vial washer, temperature-controlled chambers and autoclave loads

• Must have experience with the generation of deviations and CAPAs.

• Highly capable of developing Validation Plans and Process Qualifications

• Working with a team to ensure all aspects of activity within the Process development and Validation group adhere to required policies and procedures, including safety and training.

• Investigate/troubleshoot validation problems, as well as, conduct some statistical analysis of testing results

 

 

Job Requirements:

• Bachelor’s degree in a science / engineering field.

• Highly capable of developing, executing and reviewing validation lifecycle protocols.

• Knowledge of validation principles, standard concepts, practices, procedures and requirements in GMP regulated environments.

• Experience with facility qualification and process validation, and with knowledge of production.

• Proven capability to assess processes, equipment, and products for sources of variation, ability to analyze data and reach appropriate conclusions, and to perform and appropriately document deviations and investigations.

• knowledge of mixing, filling, filtration and sterilization process as it relates to FDA manufacturing

• Knowledge of USP, EP, JP and FDA requirements.

• Proven track-record of leading teams and project management experience is highly desired

• Experience with Microsoft Word and Excel.