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Quality Assurance Validation Specialist
2 months ago
The Validation Engineer will play a crucial role in ensuring the quality and compliance of processes and equipment within the biotechnology and pharmaceutical sectors. This position involves the creation and execution of validation protocols and reports, as well as comprehensive documentation of all related activities.
Key Responsibilities:- Develop and write detailed qualification and validation protocols, reports, and other essential documentation.
- Conduct thorough validation activities for processes and equipment, including data collection, statistical analysis, and protocol approval.
- Draft validation plans and assist in formulating specifications for user, functional, and design requirements, as well as manufacturing process protocols.
- Facilitate risk assessments and contribute to the generation of process Failure Mode and Effects Analysis (pFMEAs).
- Utilize statistical software tools, such as MiniTab, to devise effective process validation strategies.
- Oversee the validation of aseptic processes and drug substance/drug product manufacturing, including formulation studies and filling processes.
- Implement temperature and humidity mapping procedures.
- Conduct mapping for various storage environments, including warehouses, cold rooms, freezers, and stability chambers.
- Write and execute mapping protocols, including initial qualifications and remapping.
- Prepare comprehensive summary reports based on validation activities.
- Utilize MadgeTech data loggers and software for data collection and analysis.
- Perform periodic reviews of validation documentation and processes.
- Evaluate equipment such as packaging lines, mixers, and utilities to ensure compliance with quality standards.
- Bachelor's degree in Engineering, Science, or a related technical field.
- A minimum of 3-5 years of experience in a regulated manufacturing environment, specifically within the biotechnology, pharmaceutical, or medical device industries.
- Proficient in design documentation and validation processes, including IQ, OQ, PQ, PV, and CSV.
- Strong understanding of quality systems and process excellence methodologies.
- Exceptional written and verbal communication skills, with a focus on technical writing.
- Ability to collaborate effectively within a team and adapt to a fast-paced work environment.
- In-depth knowledge of FDA and cGMP regulations and documentation practices.
- Proficient in Microsoft Office Suite, including Word, Excel, and PowerPoint.
- Experience working with multiple clients across various projects.
