Commissioning, Qualification
4 weeks ago
We're recruiting on behalf of a prestigious global leader in Pharma Engineering, headquartered in Pune.
Job Title: CQV Engineer – Pharma Equipment
Location: Pune, India (with travel across India and internationally for extended durations)
Experience: 3-6 years in Commissioning, Qualification, and Validation (CQV) of pharmaceutical equipment
Job Description:
As a CQV Engineer , you will play a critical role in ensuring that pharmaceutical equipment is properly commissioned, qualified, and validated for use in manufacturing operations. This role involves working closely with cross-functional teams to ensure equipment meets regulatory standards and operational requirements. You will handle a wide variety of pharma equipment across various projects, contributing to the delivery of high-quality, regulatory-compliant pharmaceutical systems.
Key Responsibilities:
- Commissioning: Oversee the commissioning of pharmaceutical process equipment, ensuring it meets design specifications and is ready for operational use.
- Qualification & Validation: Lead the Qualification (IQ, OQ, PQ) and Validation processes for pharmaceutical equipment and systems.
- Documentation: Prepare, review, and execute validation protocols such as User Requirement Specifications (URS), Risk Assessments (RA), Design Qualification (DQ), Factory Acceptance Test (FAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Compliance: Ensure all equipment complies with Good Manufacturing Practices (GMP), Good Automated Manufacturing Practice (GAMP), and other regulatory standards such as FDA, EMEA, and local guidelines.
- Cross-Functional Coordination: Work with project managers, clients, and engineering teams to ensure smooth execution of commissioning and validation activities.
- Troubleshooting: Identify and resolve issues related to equipment performance during validation and qualification stages.
- Regulatory Audits: Assist in regulatory audits by providing required documentation and technical explanations.
Requirements:
- Bachelor’s degree in Mechanical, Chemical, Electrical Engineering, or a related field.
- 3-6 years of experience in CQV of pharmaceutical process equipment, ideally within OSD (Oral Solid Dosage), injectable, or biotech environments.
- Strong knowledge of GMP, GAMP, and validation lifecycle principles.
- Experience with validation protocols such as URS, DQ, FAT, IQ, OQ, and PQ.
- Excellent problem-solving and communication skills.
- Ability to manage multiple projects and coordinate with internal and external stakeholders.
- Willingness to travel extensively across India and internationally for extended project assignments.
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