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Johnson & Johnson Innovative Medicine · 1 day ago

Senior Commissioning, Qualification, and Validation (CQV) Engineer

Spring House, PA

Full-time

Onsite

Mid, Senior Level

4+ years exp

Johnson & Johnson Innovative Medicine is dedicated to healthcare innovation, focusing on developing treatments and cures for complex diseases. They are seeking a Senior Commissioning, Qualification, and Validation (CQV) Engineer to support the qualifications for a highly automated CAR-T Clinical Manufacturing facility, ensuring compliance and safety in operations.

Pharmaceuticals

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

Qualification

CQV engineeringGMP standardsAutomated production systemsKNEAT softwareCell processing techniquesAnalytical reasoningTechnical researchSituational awarenessEmerging technologiesProblem solving

Required

Bachelor's degree in Engineering, Life Sciences, or a related field

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

Preferred

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

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.