Job Title:
This role involves supporting the qualification of pharmaceutical equipment, utilities, and systems used in sterile injectable manufacturing.
Responsibilities
* Develop, execute, and review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for sterile manufacturing equipment.
* Ensure compliance with cGMP, FDA, EMA, and Annex 1 requirements for validation activities.
* Perform risk assessments (e.g., FMEA) to determine validation strategies and critical parameters.
* Maintain the validated state of manufacturing equipment, clean utilities, and process support systems.
Key Equipment and Systems
* Qualify and validate aseptic filling lines, lyophilizers, autoclaves, depyrogenation tunnels, and isolator/RABS systems.
* Support clean utilities qualification (e.g., WFI, clean steam, compressed air, HVAC).
* Ensure validation of automation and control systems (SCADA, PLC, MES) where applicable.
Regulatory Compliance and Support
* Author and review validation documentation, including Validation Master Plans (VMP), protocols, and reports.
* Support audits and regulatory inspections by providing validation data and technical justifications.
* Ensure adherence to Annex 1, ICH Q9 (Risk Management), ICH Q10 (Quality Systems), and FDA Process Validation Guidance.
Deviation Management and Change Control
* Investigate validation deviations and non-conformances, implementing corrective and preventive actions (CAPAs).
* Assess the impact of equipment modifications and process changes on validated state.
* Collaborate with Manufacturing, Quality, and Engineering teams to ensure smooth execution of validation activities.
Continuous Improvement and Technology Upgrades
* Implement Lean and Six Sigma principles to optimize validation processes and reduce qualification cycle times.
* Support adoption of new technologies in aseptic processing, automation, and real-time monitoring.
* Evaluate requalification strategies and periodic review programs to ensure compliance and efficiency.
Requirements
* Bachelor's or Master's degree in Engineering (Mechanical, Chemical, Biomedical, or related field) or Life Sciences.
* 5–7 years of experience in validation, equipment qualification, or technical services within sterile injectables manufacturing.
* Knowledge/familiarity of endotoxin spiking procedure – could help with micro resource shortage with respect to depyrogenation tunnel qualification.
* Lean Six Sigma or ASQ Certified Quality Engineer (CQE) certification.
* Familiarity with Process Analytical Technology (PAT) and digital validation tools.
Technical Skills
1. Expertise in IQ/OQ/PQ for aseptic processing equipment and utilities.
2. Strong understanding of cGMP, FDA, EMA, and Annex 1 guidelines.
3. Experience with validation lifecycle approach (URS, FAT/SAT, PQ).
4. Knowledge of data integrity (ALCOA+ principles) and computerized system validation (CSV).
5. Practical familiarity with environmental monitoring systems and cleanroom qualification.
6. Knowledge of autoclave and depyrogenation tunnel operation.
7. Knowledge of load preparation – thermocouple calibration and placement.
8. Handling of biological indicators