Cqv Lead

PharmEng is a leading Pharmaceutical and Biopharmaceutical Consulting company committed to delivering innovative solutions for our industries challenges. We pride ourselves on our dedication to quality, safety, and excellence in everything we do. As we continue to grow, we are seeking a highly skilled and motivated CQV Engineer to join our team.

**Job Title**: CQV Lead
**Location**: Melbourne, Australia
**Type**: Full-Time/Contract

**Job Overview**:
The CQV Lead is responsible for leading and overseeing the commissioning, qualification, and validation activities for equipment, facilities, utilities, and systems in the pharmaceutical, biotechnology, or manufacturing industries. This role ensures that all systems are properly designed, installed, tested, and compliant with regulatory requirements.

**Key Responsibilities**:

- ** Leadership & Management**:

- Lead and manage a team of CQV engineers and specialists.
- Develop and maintain project timelines, budgets, and resource allocation for CQV activities.
- Act as the primary point of contact between project teams, quality assurance, and regulatory bodies.
- ** Commissioning**:

- Oversee the commissioning activities, ensuring that all equipment and systems are installed correctly and operate according to specifications.
- Develop and execute commissioning protocols and reports.
- ** Qualification**:

- Lead the qualification efforts (IQ/OQ/PQ) for equipment, facilities, utilities, and systems.
- Author and review qualification protocols and final reports.
- Ensure that all qualification activities meet regulatory standards (FDA, EMA, etc.) and industry guidelines.
- ** Validation**:

- Develop and manage validation strategies for new and existing systems, including process validation, cleaning validation, and computer system validation.
- Review and approve validation protocols, reports, and documentation.
- Ensure continuous validation compliance throughout the lifecycle of the product or system.
- ** Regulatory Compliance**:

- Ensure all CQV activities comply with relevant regulations, standards, and guidelines (e.g., cGMP, GAMP 5).
- Participate in audits and inspections by regulatory authorities and clients.
- Maintain up-to-date knowledge of regulatory changes and industry best practices.
- ** Documentation & Reporting**:

- Prepare and maintain comprehensive CQV documentation, including risk assessments, change control, deviation reports, and corrective actions.
- Present regular updates and final reports to senior management and other stakeholders.
- ** Risk Management**:

- Identify and mitigate risks associated with CQV activities.
- Develop and implement risk management plans and strategies.

**Qualifications**:

- ** Education**:

- Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, or a related field. Advanced degree preferred.
- ** Experience**:

- Minimum of 7-10 years of experience in commissioning, qualification, and validation within the pharmaceutical, biotechnology, or manufacturing industries.
- Proven experience leading CQV projects in a regulated environment.
- ** Skills**:

- Strong knowledge of regulatory requirements (FDA, EMA, etc.) and industry standards (cGMP, GAMP, etc.).
- Excellent project management skills, including the ability to manage multiple projects simultaneously.
- Strong leadership and team management skills.
- Exceptional communication and interpersonal skills.
- Proficiency in CQV software tools and documentation systems.

**Other Requirements**:

- Ability to travel as required for project needs.
- Strong analytical and problem-solving abilities.
- Attention to detail and a commitment to quality.

Join Us: If you are a dedicated and highly motivated CQV Lead with a passion for ensuring the highest quality and compliance standards, we encourage you to apply. PharmEng offers a dynamic and inclusive work environment, competitive compensation, and opportunities for professional growth. Become a part of our team and contribute to the success of our industry-leading solutions.