Quality Engineer - pharmaceutical
Listed on 2026-07-01
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Engineering
Quality Engineering, Biomedical Engineer, Process Engineer, Pharma Engineer -
Quality Assurance - QA/QC
Quality Engineering
Quality Engineer
As the Quality Engineer you will be responsible for completing projects that provide general quality technical support for new and commercial product manufacturing operations and validation testing of production quality systems.
Key Duties/ResponsibilitiesEssential Functions - These duties are essential to the effective performance of the key functions that are required for this position.
- Pharmaceutical Production Systems Validation Support.
- Write validation test protocols and technical reports. Protocols types include Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Performance Qualification (PPQ).
- Perform monitoring, sampling, and testing to validate equipment, systems, and manufacturing/packaging processes per validation test protocols.
- Drives Process Validation Program (Process and Equipment) including Continued Process Verification (Stages 2 and 3 of 2011 FDA Guidance on Process Validation).
- Drives Cleaning Validation and Verification Program.
- Drives Computerized Systems Validation Program including 21 CFR Part 11 compliance and data integrity risk assessments.
- Interacts directly with customer on deviations and Cleaning and process validation strategy for assigned projects.
- Reviews and validates Electronic Speadsheets.
- Assesses regulatory impact of deviations, changes to equipment and batch records, materials and calibrations from a validation perspective.
- Analyze validation test data to provide statistical conclusions and recommendations to customers.
• Knowledge of manufacturing equipment and processes.
• Working knowledge of cGMP, ISO, ISPE, ANSI/ASQ standards and guidelines.
• Ability to observe and understand cause/effect phenomena and apply scientific methods to gain technical information and solve problems.
• Ability to systematically collate, organize, and interpret data, as well as to derive problematic solutions from observed data.
• Basic working knowledge of ISPE GAMP 5 guideline concepts for GxP computerized system.
• Working knowledge of risk management and risk management tools and their applications.
Education and Experience:• Bachelor’s degree in engineering or life science fields OR 2 years of college or vocational education (preferably in engineering or life science fields) with 2-5 years of experience in the
pharmaceutical and/or medical device industries.
2 to 5 years experience in the pharmaceutical and/or medical device industries. LOCAL CANDIDATES ONLY AND MUST BE U.S.
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