Sr. Engineer, Commissioning, Qualification, and Validation
$130,800–$209,400 year
On-siteNorwood, Massachusetts, United States or Quality, Georgia, United States
Job Summary
Manage commissioning, qualification, and validation activities for the company's Good Manufacturing Practices (GMP) manufacturing facility, ensuring validated status of site facilities, utilities, equipment, and processes. Track re-qualification program metrics, own quality records including Change Controls and CAPAs, and lead deviation investigations for manufacturing processes and laboratory instruments. Provide subject matter expertise for equipment such as Controlled Temperature Units and Bioreactors, while reviewing contractor deliverables and managing priorities against identified timelines. Participate in multi-functional teams to meet global regulatory requirements and drive continuous quality system improvements. May telecommute up to 30%.
Required Qualifications
- Bachelor's degree in Pharmaceutical Sciences or related life science field
- 5 years of progressive post-baccalaureate experience in the position offered or as Senior Validation Engineer, Validation Engineer, CQV Engineer or related position in a cGMP manufacturing environment
- Writing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Protocols and Reports
- Authoring Validation-related Change Controls, Deviations, and Investigations
- Executing Validation activities across various projects
- Applying Continuous Improvements to periodic review and requalification programs
- Applying manufacturing equipment knowledge to understand and develop testing requirements
- Manage the commissioning, qualification, and validation activities for the company's Good Manufacturing Practices (GMP) manufacturing facility
- Ensure the validated status of site facilities, utilities, equipment, and processes is established and maintained in accordance with internal procedures, regulatory requirements, and industry guidance and standards
- Track and report status on metrics relevant to the re-qualification program activities and responsibilities
- Own quality records such as Change Controls, Deviations, Corrective and Preventative Actions (CAPAs), and continuous improvement initiatives related to validation activities
- Lead investigation and review deviation investigations related to manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments
- Provide validation subject matter expertise and support for equipment and systems in use, including Controlled Temperature Units such as Refrigerators, Freezers, Incubators; Analytical Instruments used for in-process and quality control testing; and Manufacturing Unit Operations including Ultrafiltration, Chromatography, Mixers, Tanks and Vessels, and Bioreactors and Fermenters, among others
- Participate in multi-functional department teams for validated process, equipment, utilities, method, and computer systems, to meet established timeframes for project implementations that support business needs and meet global regulatory requirements
- Participate in continuous quality system improvements and support implementing improvements in the GMP Validation and Change Control Programs
- Review deliverables by contractors and consultants in the day-to-day execution of Commissioning, Quality and Validation (CQV) scope, and manage contractor priorities
- Drive results by owning and completing validation initiatives and projects against identified timelines
- May telecommute up to 30%
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