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 Click
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