Sr. Commissioning Qualification & Validation Engineer

About the role

The Sr. CQV Engineer, under limited supervision, will lead efforts and execute the commissioning and qualification program at Lupin Research Inc. As a senior member of the team, you will contribute your knowledge, experience, and skills toward the site's goals and objectives. You will be responsible for assessing, reviewing, generating, and/or approving all required commissioning and qualification documentation and verifications to demonstrate the fitness of equipment, facilities, and utilities for processes and products.

Responsibilities

• Write, review, approve, execute, or oversee the execution of commissioning and qualification documentation such as Commissioning Protocols, IQ, OQ, and PQ for equipment, facilities, and utilities.
• Lead or contribute to the successful completion of projects of varying complexity requiring commissioning and qualification, managing your time and resources to meet department and site goals.
• Coordinate the execution of C&Q deliverables.
• Gather and safely manage data acquired during C&Q activities to ensure its integrity and efficient use for GMP decisions.
• Ensure the qualified state of systems is maintained and any impacts are adequately mitigated following Lupin policies and procedures.
• Assess potential impacts of changes to qualified systems and implement validation best practices to continuously improve the site validation program.
• Assist in troubleshooting or resolving deviations or failures noted during commissioning or qualification of critical equipment, facilities, or utilities.
• Participate in presenting results to regulatory agencies working with Lupin Research Inc.

Requirements

• Bachelor’s degree in science with at least 5 years of experience, or a Master’s degree in an associated field with at least 3 years of experience.
• Ample knowledge and understanding of 21 CFR 211, 820, and Part 11.
• Ample knowledge and understanding of applicable ISO standards.
• Familiarity with applicable ISPE Guidelines.
• Strong technical knowledge and experience with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems, particularly related to inhalation, sterile products, and medical devices.
• Experience with periodic assessment of the qualified state of equipment and utilities.
• Demonstrated ability to work and communicate effectively cross-functionally.
• Results-driven self-starter who can work independently or in partnership with others, with limited supervision.
• Excellent oral presentation and communication skills.
• Flexibility to work off-shifts and/or weekends when required.

Skills

• Collaboration
• Customer Centricity
• Developing Talent
• Innovation & Creativity
• Process Excellence
• Result Orientation
• Stakeholder Management
• Strategic Agility