Senior Commissioning, Qualification, and Validation (CQV) Engineer

Johnson & Johnson • Malvern, PA

5d • Onsite

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for a Senior Commissioning, Qualification, and Validation (CQV) Engineer to join our Team in Spring House, PA. This position is part of the Site Engineering Team, which is the asset-management team consisting of Automation, Engineering/CQV and Maintenance for clinical labs, GxP warehouse operations, cell banking, and other GxP labs in Springhouse and Malvern, PA. We are seeking a motivated and detail-oriented subject matter expert (SME) in CQV (Commissioning, Qualification, and Validation) to join our team. The primary work location is in Spring House, PA, supporting the qualifications associated with a highly automated CAR-T Clinical Manufacturing facility, the future operation and asset life cycle management. This may require supporting our other Large Molecule Clinical Production Site located in Malvern, PA.

Requirements

• Minimum 4 years of experience in CQV engineering within the pharmaceutical or biotechnology industry.
• In depth knowledge of current GMP standards and guidelines related to equipment, utilities, and facilities commissioning and qualification (e.g., ISO, EN, ICH, FDA, ISPE)
• Ability to prioritize and manage the workload and as required, be able to manage shifting priorities based on critical deadlines so that business needs are always met
• Service mentality and ability to proactively collaborate with teams and partners, working hands-on on aspects of C&Q tasks, while identifying areas of improvement
• Bachelor’s degree in Engineering, Life Sciences, or a related field.

Nice To Haves

• Certification in CQV or related field (e.g., ASQ, ISPE).
• Experience with automated production systems and controls
• Familiarity with the latest developments in Cell and Gene Therapy production processes/equipment
• Experience with KNEAT paperless validation software
• Knowledge of cell processing robotics and automation
• Understanding of aseptic and cell processing techniques
• Experience with equipment / systems commissioning/qualification/validation, process automation associated with cell therapy (CAR-T) processes

Responsibilities

• Ownership for the development and execution of the Project Validation Master Plan (PVMP)
• Support the writing and approval of URSs (User Requirement Specifications) for facilities, equipment and systems.
• Lead the writing and execution of Impact Assessments for equipment and facilities, IQ & OQ, and Re-qualification, as well as PQ activities
• Ensure flawless execution of Commissioning, Qualification, and Re-qualification works for manufacturing and laboratory equipment, execution systems, as well as facilities and utilities
• Ensure compliance with all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WI’s and Company policies and corporate standards
• Support investigations, deviations, corrective and preventive actions towards successful timely and compliant closure
• Leading CQV role in compliance inspections / audits within area of responsibility
• Provide leadership and act as expert in the field CQV
• Develop & maintain in-depth understanding of the CAR-T manufacturing processes (including sound scientific understanding), operational procedures and manufacturing environment (Facilities, Utilities, Equipment, Systems, Processes)
• Conduct risk assessments and develop mitigation strategies to ensure compliance and safety in operations.

Benefits

• An opportunity to be part of a global market leader.
• A dynamic and inspiring working environment.
• Career opportunities and continuous personal and professional development in areas of technology and leadership.
• Personal Development Plan – such as access to further education & training, mentoring and coaching, development opportunities on-the-job or through exciting projects.
• Be part of a strong global network of talent and expertise, with opportunities to learn or move to different cultures and work environments.
• Many employee benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees