Prepare and execute Computer Validation, equipment qualification plans and protocols. Write Final Summary Reports that summarize executed qualifications/validations. Assist in the development, coordination and execution of qualifications/validation protocols for systems governed by federal regulations as applicable in the pharmaceutical industry. Coordinate validation related activities in regards to equipment and processes being deployed in GMP environments.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Develop and execute equipment qualification protocols for all manufacturing, processing, and packaging equipment and facilities/utilities supporting these operations.
- Develop and execute process validation protocols for all manufacturing and packaging processes of commercial products (and R&D products as applicable).
- Develop and execute cleaning validation/verification protocols for all commercial and R&D manufacturing, processing, and packaging equipment.
- Perform proper and timely sampling of in-process/intermediate products, finished products, rinse water and surface swabbing for testing as outlined by validation/qualification protocols.
- Perform physical testing from representative samples.
- Analyze data, utilizing statistical methods, generated by validation studies performed by the Validation group to determine process capabilities.
- Investigate and resolve deviations/exceptions from the predefined acceptance criteria.
- Draw conclusions from data, observations, deviation/exception and investigation as to whether process is considered valid.
- Write summary reports (closeout report when applicable) for validation/qualification protocols following criteria as outlined within the validation/qualification procedures and policies.
- Ensure protocols, verifications, validation plans and summary reports generated during validation/ qualification activities are stored according to procedure.
- Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
- Knowledge of FDA regulated biotechnology or drug validation requirements including knowledge of FDA 21 CFR Parts 210 and 211.
- Knowledge of Analytical Balance, LOD Instrument, Micrometer, Friabilator, Hardness Tester, Calculator, Particle Size Analyzer, Disintegration Apparatus, Viscometer.
- Knowledge of Statistical software and calculations.
- Knowledge of manufacturing processes, sampling techniques, government regulations and guidelines pertaining to those areas.
- Knowledge of SCADA control system.
- Strong understanding of cGMPs and validation/qualification concepts.
- Ability to read, program, troubleshoot PLC Ladder Logic and HMI software.
- Ability to analyze pharmaceutical processes to determine critical parameters and critical quality attributes and design testing in the form of protocols to ensure robust and repeatable process. Must have in-depth knowledge of equipment set-up and operation, facility qualifications, master validation policies and protocol generation, and protocol execution.
- Bachelor's degree in Chemistry, Pharmacy, Engineering or related Science; or equivalent combination of
- Bachelor's degree and pertinent, progressive experience in pharmaceutical or other highly regulated industry.
- Three years' proven experience in validation, with particular knowledge of 21 CFR Part 210 and 211.
Experience in 21 CFR Part 11 desired.
Job Type: Full-time
Salary: $30.00 to $37.00 /hour
- Health insurance
- Dental insurance
- Vision insurance
- Retirement plan