Project Mgr QA Validation (Fill Finish Oversight)

We are looking to fill a Project Manager Validation (Fill Finish Oversight) position to our growing team. This position is responsible for providing quality oversight of validation and qualification of equipment, systems, and processes in accordance with regulatory requirements. 

In this role, a typical day may include: 

• Responsible for compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions. 

• Generates implements and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria. 

• Analyzes the results of testing and determines the acceptability of results against pre-determined criteria. 

• Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements. 

• Reviews, edits, and approves deviation notifications, deviation investigations, and corrective actions. 

• Reviews, edits, and approves change control and SOPs. 

• Collaborates with functional departments to resolve issues. 

• Coordinates with other departments or outside contractors/vendors to complete validation tasks. 

• Reviewing and providing quality oversight of validation activities including but not limited to: Shipping, Equipment, and QC processes. 

• May trains/advise less experienced personnel. 

• May directly supervise contingent workers. 

• Provides direction and assigns work to full time employees and contingent workers to meet goals and deadlines. Coordinates with other departments or outside contractors/vendors to complete validation tasks. 

• Manage and drives projects and programs. 

• Presents project and program status and metrics to Senior Management. Act as Technical Subject Matter Expert (SME) in at least one area (e.g., SIP Qualification, Cleaning Validation, Lab Equipment Qualification, Cleanroom Qualification) 

• Must be able to present in a “pressure test” scenario the technical area that they are SME for 

• May present at both internal and external (regulatory) audits 

This role might be a fit for you if you: 

• Have previous quality or process validation experience in DP or LDP preferred 

• Are excited to work in a start-up environment 

• Have validation experience in a GMP environment; drug product validation experience preferred 

• Have a continuous improvement mentality to identify and implement improvement opportunities 

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

• Project Manager QA Validation: 10+ years 

• Sr Project Manager QA Validation: 12+ years 

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