Senior Commissioning, Qualification, and Validation (CQV) Engineer at Johnson & Johnson

Spring House, Pennsylvania, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

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 workload and shifting priorities based on critical deadlines to meet business needs
Service mentality and ability

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 of 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

Skills

Key technologies and capabilities for this role

CQVCommissioningQualificationValidationGMPCAR-T ManufacturingAutomationAsset ManagementGxPProject Engineering

Questions & Answers

Common questions about this position

What is the primary work location for this Senior CQV Engineer role?

The primary work location is in Spring House, PA, with potential support for the site in Malvern, PA.

What are the key responsibilities of this position?

Key responsibilities include ownership of the Project Validation Master Plan (PVMP), supporting URS development, leading impact assessments, IQ/OQ/PQ execution, ensuring compliance with cGMPs and regulations, and supporting investigations and audits.

What skills or expertise are required for this Senior CQV Engineer role?

The role requires being a motivated and detail-oriented subject matter expert (SME) in CQV (Commissioning, Qualification, and Validation), with experience in PVMP, URS, impact assessments, IQ/OQ/PQ, and cGMP compliance.

What team will this position be part of?

This position is part of the Site Engineering Team, which handles asset-management including Automation, Engineering/CQV, and Maintenance for clinical labs, GxP warehouse operations, cell banking, and other GxP labs in Springhouse and Malvern, PA.

What makes a strong candidate for this Senior CQV Engineer position?

A strong candidate is a motivated, detail-oriented subject matter expert in CQV with experience leading validation activities in a GxP environment, particularly for highly automated clinical manufacturing facilities.

Johnson & Johnson

Healthcare products in pharmaceuticals and devices.

About Johnson & Johnson

Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.

New Brunswick, New JerseyHeadquarters

1886Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

J&J faces a class action lawsuit in Australia over ineffective cold and flu medications.

Former J&J executives joining other firms could lead to increased competition.

Ongoing legal battles, like the lawsuit against Cigna, pose financial liabilities for J&J.

Differentiation

J&J operates in three segments: pharmaceuticals, medical devices, and consumer health.

The company invests heavily in R&D for innovative medical solutions and products.

J&J is committed to diversity, equity, and inclusion in its workplace culture.

Upsides

J&J's collaboration with Helsinki University Hospital focuses on value-based healthcare models.

The rise of personalized medicine offers J&J opportunities in targeted therapies.

Increased focus on digital health solutions presents expansion opportunities for J&J.

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