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SalaryPharmEng is a leading Pharmaceutical and Biopharmaceutical Consulting company committed to delivering innovative solutions for our industries challenges. We pride ourselves on our dedication to quality, safety, and excellence in everything we do. As we continue to grow, we are seeking a highly skilled and motivated CQV Engineer to join our team.
Job Description:
PharmEng is looking for a detail-oriented and results-driven CQV Engineer to play a key role in ensuring the successful commissioning, qualification, and validation of Solid Dose Manufacturing equipment and building expansion including WIP skids, AHUs and dust collectors and other miscellaneous equipment associated with Solid Dose Manufacturing. The CQV Engineer will work closely with cross-functional teams, including engineering, quality, and regulatory teams, to ensure compliance with industry standards and regulatory requirements while meeting our quality and performance standards.
Key Responsibilities:
1. Commissioning:
o Collaborate with engineering teams to plan and execute commissioning activities.
o Develop commissioning plans, protocols, and reports associated with production equipment and room qualifications.
o Perform equipment and system checks to ensure functionality.
o Troubleshoot and resolve commissioning issues promptly.
2. Qualification /Validation:
o Create qualification protocols and test plans for equipment, systems, and processes.
o Execute qualification activities, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
o Document and analyze qualification test results.
o Identify and address any deviations from established specifications.
o Collaborate with cross-functional teams to address and resolve validation discrepancies.
o Develop and execute validation protocols for processes and systems.
o Ensure validation activities are compliant with industry standards and regulatory requirements.
o Maintain and manage validation documentation and records.
o Complete Summary Reports to finalize the qualification of equipment and rooms.
3. Regulatory Compliance:
o Stay updated with industry regulations and guidelines related to commissioning, qualification, and validation.
o Ensure all CQV activities are in compliance with relevant standards and regulations (e.g., FDA, GMP, GAMP).
4. Documentation and Reporting:
o Maintain accurate and organized records of all CQV activities.
o Prepare clear and comprehensive reports on commissioning, qualification, and validation results.
o Communicate findings, deviations, and corrective actions effectively to relevant stakeholders.
Qualifications:
- Bachelor's degree in engineering or a related field (e.g., Chemical, Mechanical, Biomedical).
- Proven experience in commissioning, qualification, and validation within a relevant industry.
- Strong knowledge of industry standards, regulations, and guidelines.
- Excellent problem-solving skills and attention to detail.
- Effective communication and teamwork abilities.
- Proficiency with relevant software tools and documentation systems.
- Strong organizational and project management skills.
Preferred Qualifications:
- Professional certifications in CQV or related fields.
- Experience with risk-based validation approaches.
PharmEng is an equal opportunity employer and welcomes candidates of all backgrounds to apply.
