CQV Engineer

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Job Description

About the role:

The CQV Engineer reports to the Engineering Services Manager and will participate in:

• All Commissioning, Qualification and Validation (CQV) activities for Facilities, Utilities and Equipment (FUE) systems on site, along with equipment re-qualification requirements.
• Provide CQV support to locally managed capital projects that are performed on site.

We are looking for a deep experience of the validation requirements associated with a pharmaceutical manufacturing facility.

How you will contribute:

• Support the commissioning, qualification and validation of all process equipment, facilities and utilities on site.
• Help manage ongoing equipment re-qualification and periodic review requirements.
• Develop and deliver annual equipment re-qualification requirements.
• Provide CAPEX team with validation support.
• Review vendor documents to support commissioning and qualification requirements.
• Complete the review and execution of validation plans, URSs/DQ/FATs/SATs/IQ/OQ protocols/reports.
• Ensure validation non-conformances or deviations are minimised during execution of CQV activities. For issues that do arise ensure they are closed out promptly.
• Oversee vendor/ contractors on site during commissioning activities.
• Ensure compliance with current industry regulations relating to qualification and validation.
• Support department performance.

Environmental Health and Safety:

• Participate in site EHS activities and ensure compliance with legislation and best practice.
• Foster an ethos and culture of safety awareness, where safety is accepted as an necessary part of the business.
• Work with all site personnel, contractors and visitors to ensure that all safety policies, procedures and regulations are observed across the site on an ongoing basis.

Training:

• Preparation and delivery of training material.
• Ensure completion of all SOP training and assessment tasks.

What you bring to Takeda:

• 3rd level Engineering or Science Degree, or equivalent
• Experience with regulatory audits, in particular representing facility equipment qualification type issues.
• At least three years validation experience (CQV) within a pharmaceutical setting with experience in computer system validation (CSV) an advantage.
• Experience with mechanical installations/modifications tests in the API area and capsule manufacturing processes, including equipment such as capsule fillers, blister packaging lines, reactors, milling, and utilities (e.g., purified water and nitrogen systems).
• Knowledge of CSV (FDA 21 CFR Part 11 requirements) for manufacturing systems.
• Knowledge of Engineering practices (e.g., ISPE, ASME, ASTM).

• Knowledge of validation practices and regulatory guidelines for a pharmaceutical facility.
• Experience with regulatory audits, in particular representing equipment qualification type issues.

• Experience writing validation plans, requirements gathering, design documentation, system configuration, system testing and troubleshooting
• Experience in Kneat Validation Software desirable.

What you can look forward to with us:

• Competitive Salary: Including performance-based bonuses.
• Retirement Plan: Employer contributions to your retirement plan.
• Comprehensive Insurance: Employer-funded private medical insurance with dependants’ cover, life insurance, and flexible options like dental insurance, partner life insurance, and serious illness protection.
• Electric Charging Points: Available at parking locations.
• Employee Assistance Program: Support for personal and professional challenges.
• Wellbeing and Engagement: Dedicated teams to support your wellbeing.
• Family-Friendly Policies: Supportive policies for a balanced work-life.
• Generous Vacation: 26 vacation days plus additional days for service milestones and humanitarian volunteering leave.
• Development Opportunities: Coaching, mentoring, educational programs, and formal training.
• Subsidized Canteen: Enjoy meals at a reduced cost.
• Flexible Benefits: Options like fuel card, bike to work, commuter ticket, and insurance deals.

More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

If you are interested in this opportunity, we look forward to receiving your application via our online tool!

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