CQV Engineer (Aseptic/ Sterile Manufacturing)

Responsibilities

• Execute commissioning and qualification (IQ/OQ/PQ) activities for process equipment, clean utilities, and facilities in aseptic manufacturing areas.
• Develop, review, and approve validation protocols and reports in alignment with GMP, FDA, and EU regulatory requirements.
• Support aseptic processes, including cleanroom qualification, HVAC systems, and environmental monitoring (EM).
• Perform risk assessments (e.g., FMEA, impact assessments) to define validation strategies.
• Ensure compliance with sterility assurance requirements, including contamination control and aseptic processing guidelines.
• Collaborate with cross-functional teams (Engineering, QA, Production) to support project timelines and deliverables.
• Manage and support deviations, CAPA, and change controls related to CQV activities.
• Participate in FAT/SAT activities, ensuring systems meet user requirements specifications (URS).
• Support regulatory audits and inspections, providing documentation and technical justifications where required.
• Ensure all documentation is maintained in accordance with data integrity (ALCOA+) principles.
• Required Qualifications
• Bachelor's Degree in Engineering, Life Sciences, or related discipline.
• Minimum 3-5 years of CQV experience within the pharmaceutical or biotechnology industry.
• Hands-on experience in aseptic or sterile manufacturing environments (e.g., fill-finish, cleanroom operations).
• Strong knowledge of GMP regulations, Annex 1, FDA guidelines, and validation lifecycle.
• Experience with clean utilities (WFI, clean steam, compressed gases) and HVAC systems.
• Familiar with EM programs, cleanroom classifications, and contamination control strategies.
• Proven experience in protocol writing and execution.
• Strong problem-solving skills and ability to handle deviations and investigations.
• Excellent communication and stakeholder management skills.
• Why join us?
• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.
• How to apply
• Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!
• Please submit your resume, outlining your qualifications and experience relevant to the role, here.

Additional Information

About No deviation At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation. We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development - empowering our team members to grow personally and professionally. Position Overview We are seeking a highly skilled Commissioning, Qualification, and Validation (CQV) Engineer with strong experience in aseptic and sterile manufacturing environments. The successful candidate will be responsible for executing CQV activities across equipment, utilities, and cleanroom systems, ensuring compliance with GMP and regulatory requirements.

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