Job Description

Job Summary

We are seeking a highly skilled and experienced CQV (Commissioning, Qualification, and Validation) Manager to oversee the CQV activities for our biopharmaceutical capital project. In this role, you will be responsible for ensuring that the commissioning, qualification, and validation processes are executed efficiently and effectively in accordance with regulatory requirements and project timelines.

Responsibilities:
~ Develop and implement CQV strategies, plans, and protocols for the biopharmaceutical capital project.
~ Lead a team of CQV professionals (internal & external) to execute commissioning, qualification, and validation activities, including FAT/SAT, IQ/OQ/PQ, and process validation.
~ Coordinate with cross-functional teams, including engineering, manufacturing, quality assurance, and regulatory affairs, to ensure alignment of CQV activities with project goals.
~ Review and approve CQV documentation, including protocols, reports, and deviations, to ensure compliance with regulatory standards and project requirements.
~ Provide technical expertise and guidance on CQV-related matters to project team members and stakeholders.
~ Manage resources (internal & external) budget, and timelines for CQV activities, identifying and addressing any risks or issues that may impact project delivery.
~ Participate in regulatory inspections and audits, ensuring that CQV documentation and practices meet regulatory expectations.
~ Stay current with industry trends and best practices in CQV, incorporating new technologies and methodologies as appropriate.


Qualifications:
~ Bachelor's or Master's degree in engineering, life sciences, or related field.
~ Minimum of 8 years of experience in commissioning, qualification, and validation within the biopharmaceutical or pharmaceutical industry.
~ Demonstrated leadership experience, including managing CQV teams and projects.
~ Strong understanding of regulatory requirements and industry standards related to CQV, including FDA, EMA, and ICH guidelines.
~ Excellent communication, interpersonal, and problem-solving skills.
~ Ability to work effectively in a fast-paced, dynamic environment, managing multiple priorities simultaneously.
~ Experience with computerized systems validation (CSV) is a plus.
~ Professional certifications such as Six Sigma, PMP, or ASQ are desirable.
~ Join our team and play a key role in the successful execution of our biopharmaceutical capital project. Apply now to contribute your expertise to an exciting and impactful endeavor in the biopharmaceutical industry.


An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability

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