We are currently looking to fill a Project Manager, QA Validation position. This position will validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures.

In this role, a typical day might include the following:

• Supervising compliance of area operations, including trending of failures and evaluating efficiency of corrective actions
• Generating validation project deliverables and schedule, including integration of deliverables/schedule into larger project team plan
• Evaluating achievement versus schedule plan, and translates information to reportable metrics
• Formulating efficiency improvement to ensure timeliness of validation deliverables
• Deliver project reports to management
• Generating, executing and reviewing master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
• Preparing equipment for qualification studies and executes qualification and validation studies according to approved protocols and SOPs. Analyzes the results of testing and determines the acceptability of results against pre-determined criteria
• Investigating and troubleshooting problems which occur and determines solutions or recommendations for changes and/or improvements
• Reviewing, editing and approving deviation notifications, deviation investigations, corrective actions, change control and SOPs
• Collaborating with functional departments to resolve issues
• Coordinating with other departments or outside contractors/vendors to complete validation tasks
• May train/advise less experienced personnel, may directly supervise contingent workers

This role might be for you if you:

• Have validation experience in the pharmaceutical industry
• Can coordinate with other departments or outside contractors/vendors to complete validation tasks
• You continuously seek to improve processes for improved performance

To be considered for this role you must hold a Bachelor’s degree in Engineering, Chemistry, or Life Sciences with the following amount of related experience for each level:

• Associate Project Manager: 8 years
• Project Manager: 10 years
• Sr Project Manager: 12 years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.