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 to the site's goals and objectives by ensuring the fitness of equipment, facilities, and utilities for processes and products. This role involves maintaining the qualified state of systems in a compliant and effective manner, as well as leading or assisting in the continuous improvement of Commissioning & Qualification (C&Q) procedures and best practices.

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/or qualification.
• Manage time and resources to achieve department and site-established goals.
• Coordinate the execution of C&Q deliverables and gather and manage data acquired during C&Q activities to ensure integrity and efficient use for GMP decisions.
• Ensure the qualified state of systems is maintained and mitigate any impacts 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 success in a team environment.
• 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