Job Description
Your new company will be working in a dynamic environment where you will be responsible for the commissioning, qualification, and validation of equipment, systems, and processes used in the production of drug substances.
This role ensures that all systems operate as intended and comply with regulatory standards. You will work closely with cross-functional teams to support the successful delivery of projects.
* Perform equipment start-up and troubleshooting to ensure proper operation.
* Document commissioning activities and results.
* Develop and execute qualification protocols (IQ/OQ/PQ) for equipment, utilities, and systems.
* Ensure that all qualification activities comply with regulatory requirements and industry standards.
* Analyze qualification data and prepare comprehensive reports.
* Develop and execute validation protocols for processes and computer systems.
* Conduct risk assessments and gap analyses to identify critical process parameters and control strategies.
* Ensure validation activities are aligned with current Good Manufacturing Practices (cGMP) and regulatory guidelines.
* Experience with commissioning, qualification, and validation of biopharmaceutical equipment and systems.
* Strong understanding of cGMP, FDA, EMA, and other relevant regulatory requirements.
* Proficiency in developing and executing IQ/OQ/PQ protocols.
* Familiarity with risk-based approaches to validation.
* Excellent problem-solving and analytical skills.
* Strong project management and organizational skills.
* Effective communication and interpersonal skills.