Senior Commissioning, Qualification, and Validation (CQV) Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at 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.

Key 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 WIs 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.

Qualifications:

Education:

• Bachelors degree in Engineering Life Sciences or a related field.

Experience and Skills:

Required:

• 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

Other:

• For the first year of this assignment travel up to 25% of the time may be necessary to support FATs OEM site visits and/or other project requirements. After the first year travel of up to 5% may be needed.

This is what awaits YOU at J&J:

• 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.

• We are an equal opportunities employer.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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