Senior Manager CQV at Johnson & Johnson

Titusville, Pennsylvania, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

Expertise in Commissioning, Qualification & Validation (CQV) within pharmaceutical or biotech facilities, particularly CAR-T or advanced therapies
Strong knowledge of J&J standards for validation strategies and compliance
Experience in developing and executing Project Validation Master Plan (PVMP)
Ability to manage day-to-day C&Q and requalification activities
Proven track record in oversight and development of internal/external partnerships at site and global levels
Experience supporting writing and approval of User Requirement Specifications (URSs) for facilities, equipment, and systems
Leadership in Health Authority inspections and audits as primary point of contact for asset & facility qualification matters
Close collaboration skills with Operations, MSAT, Quality, 3rd party partners, EHS, global E&PS, and other teams
Capability to create and sustain continuous procedural improvements for C&Q efficiency
People leadership experience in Quality Engineering within Supply Chain Engineering

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
Ensure flawless execution of Commissioning, Qualification, and Re-qualification works for manufacturing and laboratory equipment, execution systems, facilities, and utilities
Lead the writing and execution of CQV-related documentation and activities
Provide day-to-day management of C&Q and requalification activities
Serve as key point of contact for all technical matters related to Commissioning, Qualification & Validation across asset lifecycle
Partner with Operations, MSAT, Quality, 3rd party partners, EHS, global E&PS to align validation strategies with standards and operational needs
Act as first point of contact during Health Authority inspections and audits for asset & facility qualification matters, ensuring successful outcomes
Create and sustain continuous procedural improvements to boost efficiency of C&Q activities
Ensure on-time qualified system turnover to the end user

Skills

CQV

Quality Engineering

Supply Chain Engineering

CAR-T

Process Validation

Manufacturing Oversight

GMP

FDA Compliance

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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