We are seeking a Drug Product Quality Systems Engineer for a 6-12 month contract (with potential for extension). This role requires 3-6 years of experience in quality systems engineering, specifically focused on drug product manufacturing. The successful candidate will work in a hybrid environment, supporting quality systems for drug product manufacturing operations.
The role involves supporting the Drug Product Manufacturing Sciences and Technology (DP MSAT) departments through monitoring process performance, data trending, analysis, and laboratory testing. The candidate will assist in the design and development of drug product processes and be part of a team responsible for industrialization, troubleshooting, and validation of these processes at both international and domestic manufacturing sites.
Responsibilities include but are not limited to:
- Performing accurate data entry into electronic systems in a timely and efficient manner
- Tracking cycle times and metrics for data entry processes
- Supporting the implementation, expansion, and continuous improvement of data aggregation and reporting systems
- Managing quality system events related to data integrity and data management, such as investigations, CAPAs, change controls, and general document approvals
- Tracking and trending process performance to improve process capability, using data analytics and/or laboratory testing to develop metrics and ensure processes are operating within the intended control strategy
- Authoring policies, technical reports, protocols, change controls, etc., in support of cGMP activities
- Leading efforts associated with Continued Process Verification (CPV), documentation, and trending of In Process Control (IPC) initiatives
- Maintaining required training status on specific work instructions and SOPs
Requirements:
- 3-6 years of experience in quality systems engineering for drug products
- Expertise in aseptic filling, auto-injector assembly, and packaging processes
- Ability to work onsite in a hybrid work environment
- Strong knowledge of regulatory compliance in drug product manufacturing
- Must be local to New York
If you're passionate about quality systems and drug product engineering, we'd love to hear from you!