Sr. Commissioning Qualification & Validation Engineer

Sr. Commissioning Qualification & Validation Engineer

The Sr. CQV Engineer, under limited supervision, will lead efforts and execute the commissioning and qualification program established in Lupin Research Inc. As a senior member of the team, your knowledge, experience and skills will contribute towards the goals and objectives of the site. You will be responsible for the assessment, review, generation and or approval of all required commissioning and qualification documentation and verifications necessary to demonstrate the fitness of equipment, facilities and utilities for our processes and products (intended use). Likewise, you will be responsible to ensure that such qualified state is maintained in the most compliant and effective manner. Also, the Sr. CQV Engineer will be responsible to lead or assist in the implementation and continuous improvement of the Commissioning & Qualification (C&Q) procedures and approaches to ensure best practices.

• Write, review, approve, execute or oversee the execution of related commissioning and or qualification documentation such as Commissioning Protocols, IQ, OQ, PQ for all sort of equipment, facilities and utilities.

• Lead or contribute in the successful completion of all type of complexity projects where commissioning and or qualification are needed. Manage own time and resources toward the achievement of department and site established goals.

• Do all necessary coordination for the execution of any of the C&Q deliverables.

• Gather and safely manage all data acquired during the C&Q activities data to ensure its integrity and efficient use for GMP decisions.

• Ensure that the systems qualified state is maintained and any impact is adequately mitigated following Lupin policies and procedures.

• Assess potential impact of changes to qualified systems; Identify and implement validation best practices to continuously improve the site validation program.

• Assist in the troubleshooting or resolution of deviations or failures noted during the commissioning or qualification of equipment, facilities or utilities deemed critical for the assurance of the quality of the product and or safety of the patient.

• Participate in the presentation of results to the different regulatory agencies working with Lupin Research Inc.

Qualification and Experience:

• Bachelor's degree in science with at least 5 years of experience or

• Master's Degree in associated field with at least 3 years of experience.

• Ample knowledge and understanding of 21CFR 211, 820 and part 11.

• Ample knowledge and understanding of applicable ISO standards.

• Must be familiar with applicable ISPE Guidelines.

• Strong technical knowledge and experience with validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems is required, as related to inhalation, sterile products and medical devices.

• Experience with periodic assessment of the qualified state of equipment & Utilities.

• Demonstrated ability to work and communicate effectively cross-functionally Team player, With limited supervision you must be results driven self-starter, who can work independently and or in partnership with others and who has success in a team environment.

• Candidate must have excellent oral presentation and communication skills.

• Must be flexible to work off-shifts and or weekends when required.

Competencies:

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